FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Leadless Pacemaker
PMA: P150033
·
Supplement: S212
·
Decision Aug 15, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P150033 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
- Micra Transcatheter Pacing System (Micra AV/VR and Micra AV2/VR2)
- PMA Number
- P150033
- Supplement Number
- S212
- 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
- August 15, 2025
- Date Received
- June 17, 2025
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for changes to the cybersecurity and adverse event information in the instructions for use for the Micra Transcatheter Pacing System.
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 |