Durata / Optisure ( Passive); / Durata / Optisure (Active)
FDA premarket approval P950022/S106 · decided 2017-06-13
Approval details
- PMA number
- P950022
- Supplement
- S106
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Durata / Optisure ( Passive); / Durata / Optisure (Active)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-05-24
- Decision date
- 2017-06-13
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Implementation of batch release analytical testing of the drug component characteristics on high voltage leads.
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |