CONTAK RENEWAL FAMILY
FDA premarket approval P010012/S149 · decided 2007-03-29
Approval details
- PMA number
- P010012
- Supplement
- S149
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONTAK RENEWAL FAMILY
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2007-03-13
- Decision date
- 2007-03-29
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES FOR THE VITALITY AND CONTAK RENEWAL FAMILIES OF DEFIBRILLATORS: 1) REQUIRE THE REED SWITCH COMPONENT SUPPLIER TO EXPOSE 100% OF THE COMPONENTS TO A HIGH MAGNETIC FIELD CONDITION OF MINIMUM OF 30MT, 10 CYCLES WITH 1 SECOND DURATION PRIOR TO SHIPPING TO GUIDANT. 2) APPLY AN ENHANCED QUALITY TEST OF 30MT THROUGH 30 CYCLES AND VERIFY THE REED SWITCH IS OPEN AFTER REMOVING THE DEVICE FROM THE MAGNETIC FIELD, TO ALL DEVICES CURRENTLY HELD UNDER A STOP ACTION NOTICE (
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510(k) clearances by this applicant
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|---|---|---|
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |