FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Leadless Pacemaker
PMA: P150035
·
Supplement: S034
·
Decision Feb 23, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P150035 in seconds
The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- Aveir DR Delivery Catheter (LSCD201)
- PMA Number
- P150035
- Supplement Number
- S034
- 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
- February 23, 2026
- Date Received
- November 20, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
approval for a manufacturing site located at Abbott Medical, Interior Lot A Road #2 Km 67.5 Santana Industrial Park Arecibo, Puerto Rico 00612 FEI: 3006705815 for manufacturing, packaging and EO sterilization.
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 |