EC Certificate - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
Supplementary Information to CE 694788
Issued
No. To: Abbott Medical
CE 694788
5050 Nathan Lane North
Issued To: Abbott Medical
Plymouth
5050Minnesota Lane North
Nathan
Plymouth
55442
USA
Minnesota
55442
USA
In respect of:
The design, development, and manufacturing of occluders, plugs, delivery and exchange
systems, catheters, sheaths, introducers, guidewires, sizing balloons, and related accessories
for cardiovascular occlusion and vascular closure.
Those aspects of Annex II related to securing and maintaining sterility in the respect of sizing
plates.
on the basis of our examination of the quality assurance system under the requirements of Council Directive
93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For
the placing on the market of class III products an Annex II section 4 certificate is required.
For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 2797):
Gary E Slack, Senior Vice President Medical Devices
First Issued: 2018-09-03 Date: 2021-03-30 Expiry Date: 2023-02-23
First Issued: 2018-09-03 Date: 2021-03-30 Expiry Date: 2023-02-23
Page 1 of 3
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Full Quality Assurance System
Supplementary Information to CE 694788
Issued To: Abbott Medical
5050 Nathan Lane North
Plymouth
Minnesota
55442
USA
Number Device Name Intended purpose per IFU
Class III
--- Amplatzer™ Septal Occluder, Amplatzer™ See CE 694948
Multifenestrated Septal Occluder -
"Cribriform" and Amplatzer™ PFO Occluder
--- Amplatzer™ Membranous VSD Occluder, See CE 694951
Amplatzer™ Muscular VSD Occluder and
Amplatzer™ P.I. Muscular VSD Occluder
--- AMPLATZER Guidewires See CE 694955
--- Amplatzer™ Delivery Systems See CE 694956
--- Amplatzer™ Duct Occluder, Amplatzer™ See CE 694957
Duct Occluder II, Amplatzer™ Duct Occluder
II Additional Sizes and Amplatzer Piccolo™
Occluder
--- Amplatzer™ Sizing Balloon II See CE 694959
--- Amplatzer™ Left Atrial Appendage Occlusion See CE 694961
Devices
--- Amplatzer™ Valvular Plug III See CE 707326
First Issued: 2018-09-03 Date: 2021-03-30 Expiry Date: 2023-02-23
Page 2 of 3
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Full Quality Assurance System
Supplementary Information to CE 694788
Issued To: Abbott Medical
5050 Nathan Lane North
Plymouth
Minnesota
55442
USA
Number Device Name Intended purpose per IFU
Class IIb
MD 0201 Vascular Plugs Indicated for arterial and venous
embolizations in the peripheral
vasculature
Class Is
MD 0106 Sizing Plates ---
First Issued: 2018-09-03 Date: 2021-03-30 Expiry Date: 2023-02-23
Page 3 of 3
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No: CE 694788
Date: 2021-03-30
Issued To: Abbott Medical
5050 Nathan Lane North
Plymouth
Minnesota
55442
USA
Subcontractor: Service(s) supplied
Abbott Medical Manufacture
177 County Road B East
St. Paul
Minnesota
55117
USA
Abbott Medical EU Representative
The Corporate Village Labelling
Da Vincilaan 11 Box F1 Packaging
1935 Zaventem
Belgium
Creganna Medical also doing business as Manufacture
Creganna Tactx Medical
5905 Trenton Lane North
Plymouth
MN
55442
USA
Page 1 of 4
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No: CE 694788
Date: 2021-03-30
Issued To: Abbott Medical
5050 Nathan Lane North
Plymouth
Minnesota
55442
USA
Subcontractor: Service(s) supplied
Creganna Medical also doing business as LSA Manufacture
5015 Cheshire Parkway
Plymouth
Minnesota
55446
USA
Isomedix Operations Inc. ETO Sterilization
380 90th Avenue NW
Minneapolis
Minnesota
55433
USA
Lake Region Medical Ltd. Manufacture
Butlersland
New Ross
Co. Wexford
Ireland
Page 2 of 4
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No: CE 694788
Date: 2021-03-30
Issued To: Abbott Medical
5050 Nathan Lane North
Plymouth
Minnesota
55442
USA
Subcontractor: Service(s) supplied
Midwest Sterilization Corporation ETO Sterilization
1204 Lenco Avenue
Jackson
Missouri
63755
USA
St. Jude Medical Costa Rica Ltda. Manufacture
Edificio #44B
Calle 0, Ave. 2
Zona Franca Coyol
El Coyol, Alajuela
Costa Rica
Sterigenics US, LLC ETO Sterilization
5725 W. Harold Gatty Drive
Salt Lake City
Utah
84116
USA
Page 3 of 4
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No: CE 694788
Date: 2021-03-30
Issued To: Abbott Medical
5050 Nathan Lane North
Plymouth
Minnesota
55442
USA
Subcontractor: Service(s) supplied
Synergy Health AST SRL ETO Sterilization
B13.1 Street 4, Avenue 1
El Coyol Free Zone
20102 El Coyol
Alajuela
Costa Rica
Page 4 of 4
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Full Quality Assurance System
Certificate History
Certificate No: CE 694788
Date: 2021-03-30
Issued To: Abbott Medical
5050 Nathan Lane North
Plymouth
Minnesota
55442
USA
Reference
Date Action
Number
03 September 2018 8955540 First Issue. Mirror certificate to CE 590631.
20 February 2019 8243107 Traceable to NB 0086.
20 March 2019 9738454 Addition of Sterigenics US, LLC, Salt Lake City, Utah USA as
significant subcontractor for ETO Sterilization.
25 October 2019 3078721 Addition of subcontractor Midwest Sterilization Corporation,
Jackson, Missouri USA for activity ETO Sterilization.
15 October 2020 3277497 Sterilization change from BIs to parametric release.
Change affecting all ETO sterilized products covered by this
certificate.
Current 3338809 Addition of subcontractor Abbott Medical (St. Paul) for
Manufacture. Removal of subcontractor Sterigenics
(Willowbrook). Addition of device table.
Page 1 of 1
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
