FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Leadless Pacemaker
PMA: P150033
·
Supplement: S166
·
Decision Jun 7, 2023
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- Micra AV TPS, Micra TPS
- PMA Number
- P150033
- Supplement Number
- S166
- 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 7, 2023
- Date Received
- March 21, 2023
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for updating the current labeling of the Micra Transcatheter Pacing System (TPS) to include jugular venous access as an additional or alternate access site.
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 |