FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Leadless Pacemaker
PMA: P150035
·
Supplement: S004
·
Decision Apr 14, 2023
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- Aveir VR Leadless Pacemaker
- PMA Number
- P150035
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- PNJ
- Generic Name
- Leadless pacemaker
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 14, 2023
- Date Received
- February 1, 2023
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for software changes in the Merlin PCS Model 3330 Software v27.0.1 and Merlint.net MN5000 v8.0.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PNJ | Leadless Pacemaker | FDA class 3 | Cardiovascular |