Accent MRI Pacemaker
FDA premarket approval P140033/S054 · decided 2020-06-26
Approval details
- PMA number
- P140033
- Supplement
- S054
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Accent MRI Pacemaker
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-02-05
- Decision date
- 2020-06-26
- Days to decision
- 142 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for Accent MRI Pacemaker Models PM1124, PM2124 and PM2224.
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |