TENDRIL SDX, ST, STS, AND OPTISCIENSE L V LEADS
FDA premarket approval P960013/S079 · decided 2016-02-17
Approval details
- PMA number
- P960013
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TENDRIL SDX, ST, STS, AND OPTISCIENSE L V LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-01-19
- Decision date
- 2016-02-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Update to the First Article Inspection procedure, an addition of pull testing of extruded tubing, a change in location for an extrusion process, and a change to the curing parameters of a polymer.
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510(k) clearances by this applicant
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |