Ampere Generator, Ampere Remote Control, Ampere Generator System Kit
FDA premarket approval P220013/S001 · decided 2023-11-29
Approval details
- PMA number
- P220013
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Ampere Generator, Ampere Remote Control, Ampere Generator System Kit
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-06-02
- Decision date
- 2023-11-29
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- design and labeling changes to the Ampere Generator and associated equipment
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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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| 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 |