PMA P150033S145
- Device
- Micra TPS, Micra AV TPS
- Applicant
- Medtronic, Inc.
- Product code
- PNJ
- Decision date
- 2022-10-16
- Generic name
- Leadless pacemaker
- Approval order statement
- Approval for new SmartSync software applications to provide support for additional families of market-released CIEDs.
Current openFDA PMA Record#
- Device
- Micra TPS, Micra AV TPS
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S145
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2022-10-16
- Decision code
- APPR
- Date received
- 2022-07-20
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for new SmartSync software applications to provide support for additional families of market-released CIEDs.