Endurity Core, Endurity, Zenex, Zenus
FDA premarket approval P880086/S321 · decided 2021-09-15
Approval details
- PMA number
- P880086
- Supplement
- S321
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Endurity Core, Endurity, Zenex, Zenus
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-07-08
- Decision date
- 2021-09-15
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for model line extensions in the Endurity, Endurity Core, Zenex, Zenus, Zenex MRI, and Zenus MRI families of pacemakers; the Quadra Assura MP, Quadra Assura, and Unify Assura families of CRT-Ds; and the Ellipse VR DR and Fortify Assura VR DR family of ICDs. This supplement also requested approval for the MR conditional labeling of a subset of these devices.
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |