Aveir VR Leadless Pacemaker
FDA premarket approval P150035/S004 · decided 2023-04-14
Approval details
- PMA number
- P150035
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Aveir VR Leadless Pacemaker
- Generic name
- Leadless pacemaker
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-02-01
- Decision date
- 2023-04-14
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- PNJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for software changes in the Merlin PCS Model 3330 Software v27.0.1 and Merlint.net MN5000 v8.0.
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