CADENCE FAMILY OF ICDS
FDA premarket approval P910023/S238 · decided 2010-07-21
Approval details
- PMA number
- P910023
- Supplement
- S238
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CADENCE FAMILY OF ICDS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-06-24
- Decision date
- 2010-07-21
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE IMPROVEMENT OF THE MANUFACTURE AND QA PROCESS BY INSERTING THE INSPECTIONS TO THE BATTERY WELDING.
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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 |