Low Voltage Active Fixation Lead
FDA premarket approval P140033/S010 · decided 2017-12-19
Approval details
- PMA number
- P140033
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Low Voltage Active Fixation Lead
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-07-03
- Decision date
- 2017-12-19
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for MR Conditional labeling for Fortify Assura ICDs, Quadra Assura and Quadra Assura MP CRT-Ds, and Durata, Optisure, Tendril MRI and Quartet lead systems.
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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 |