FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Leadless Pacemaker
PMA: P150035
·
Supplement: S039
·
Decision Jun 11, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- The AVEIR Leadless Pacemaker (LP)
- PMA Number
- P150035
- Supplement Number
- S039
- 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 11, 2026
- Date Received
- May 13, 2026
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150035/S036
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 |