IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS
FDA premarket approval P910023/S091 · decided 2006-01-10
Approval details
- PMA number
- P910023
- Supplement
- S091
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-12-23
- Decision date
- 2006-01-10
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- USE OF AN AUTOMATED SOLDERING SYSTEM FOR THE SOLDERING OF THE SENSOR FLEX AND HVPCB ASSEMBLIES.
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510(k) clearances by this applicant
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|---|---|---|
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |