Epic Plus, Epic Max Tissue Heart Valves
FDA premarket approval P040021/S054 · decided 2024-10-17
Approval details
- PMA number
- P040021
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Epic Plus, Epic Max Tissue Heart Valves
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-09-27
- Decision date
- 2024-10-17
- Days to decision
- 386 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for minor updates to the Epic Plus, Epic Plus Supra, and Epic Max tissue heart valve labeling to align with ISO 5840-2:2021 recommendations.
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510(k) clearances by this applicant
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|---|---|---|
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
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| OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459) | ABBOTT MEDICAL | 2026-04-24 |
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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 |