Endurity, Endurity Core, Assurity, Assurity+
FDA premarket approval P880086/S285 · decided 2017-08-14
Approval details
- PMA number
- P880086
- Supplement
- S285
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Endurity, Endurity Core, Assurity, Assurity+
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-07-31
- Decision date
- 2017-08-14
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Alternate supplier of the 5-pin filtered feedthrough (FFT) assembly.
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510(k) clearances by this applicant
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|---|---|---|
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |