FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Leadless Pacemaker
PMA: P150035
·
Supplement: S014
·
Decision Sep 26, 2024
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- Aveir VR Leadless Pacemaker: AveirLeadless Pacemaker (Right Ventricular), Aveir DR Leadless Pacemaker: Aveir Leadless
- PMA Number
- P150035
- Supplement Number
- S014
- 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
- September 26, 2024
- Date Received
- July 1, 2024
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for a shelf life of 24-months for the Ventricular and Atrial Aveir Leadless Pacemakers when stored at controlled room temperature 25°C with excursions permitted between 15°C and 30°C
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 |