OptiSense Steroid Eluting Cardiac Lead
FDA premarket approval P960013/S112 · decided 2020-06-17
Approval details
- PMA number
- P960013
- Supplement
- S112
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OptiSense Steroid Eluting Cardiac Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-05-18
- Decision date
- 2020-06-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Process improvements and changes associated with the optimized drug release/elution test method for batch release and annual stability for OptiSense leads MCRD component manufacturing.
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |