FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Leadless Pacemaker
PMA: P150035
·
Supplement: S003
·
Decision Jun 29, 2023
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- Aveir DR Leadless System
- PMA Number
- P150035
- Supplement Number
- S003
- 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
- June 29, 2023
- Date Received
- January 17, 2023
- Supplement Type
- Panel Track
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
- Docket Number
- 23M-3561
Advisory Committee Statement
Approval for the Aveir DR Leadless System, Aveir Leadless Pacemaker (Right Ventricular), Aveir Leadless Pacemaker (Right Atrial), Aveir Delivery Catheter, Aveir Link Module.
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 |