AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P880086/S109 · decided 2005-10-14
Approval details
- PMA number
- P880086
- Supplement
- S109
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Generic name
- Programmer, pacemaker
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-09-16
- Decision date
- 2005-10-14
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- KRG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ALTERNATE VENDOR OF QUADPOLAR FEEDTHROUGH ASSEMBLY FOR USE WITH AFFINITY, IDENTITY, INTEGRITY AND ENTITY FAMILY OF ICDS.
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510(k) clearances by this applicant
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|---|---|---|
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |