FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Leadless Pacemaker
PMA: P150035
·
Supplement: S036
·
Decision Apr 3, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- AVEIR Leadless Pacemaker, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201)
- PMA Number
- P150035
- Supplement Number
- S036
- 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 3, 2026
- Date Received
- January 20, 2026
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for a labeling expansion to update the labeling for the Aveir VR Leadless Pacemaker to include delivery of the device through the internal jugular vein.
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 |