FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Leadless Pacemaker
PMA: P150033
·
Supplement: S191
·
Decision Nov 14, 2024
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- CareLink SmartSync Micra AV App, CareLink SmartSync Micra Evolution App, CareLink SmartSync Micra VR App
- PMA Number
- P150033
- Supplement Number
- S191
- 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
- November 14, 2024
- Date Received
- September 16, 2024
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
approval for software changes to the CareLink SmartSync Device Manager to address instances of inappropriate display of the device electrical reset message, and to correct the functionality of the abort button
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 |