Amplatzer Amulet Left Atrial Appendage Occluder
FDA premarket approval P200049/S014 · decided 2025-12-23
Approval details
- PMA number
- P200049
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Amplatzer Amulet Left Atrial Appendage Occluder
- Generic name
- System, appendage closure, left atrial
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-09-30
- Decision date
- 2025-12-23
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NGV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- approval for minor dimensional changes to the hemostasis valve accessory device supplied with the Amulet LAAO as well as clarifications to your instructions for use including updates to the MRI labeling.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
| Amplatzer TorqVue Exchange System (K261631) | Abbott Medical | 2026-06-17 |
| 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 |
| EnSite™ X EP System (K260212) | ABBOTT MEDICAL | 2026-04-20 |
| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
| Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499) | ABBOTT MEDICAL | 2026-03-13 |
| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |