AFFINITY FAMILY OF PULSE GENERATORS
FDA premarket approval P880086/S079 · decided 2000-11-21
Approval details
- PMA number
- P880086
- Supplement
- S079
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFFINITY FAMILY OF PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-10-16
- Decision date
- 2000-11-21
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE ADDITION OF A LAYER OF KAPTON TAPE (A POLYIMIDE FILM) TO THE EDGE SIDE OF THE DEVICES' BATTERY CASE OF THE AFFINITY FAMILY OF PULSE GENERATORS.
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