PMA P150033S116
- Device
- Micra AV TPS, Micra TPS
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S116
- Product code
- PNJ
- Decision date
- 2021-07-16
- Generic name
- Leadless pacemaker
- Approval order statement
- Update tooling and work instructions for the assembly of your Micra leadless pacing system.
Current openFDA PMA Record#
- Device
- Micra AV TPS, Micra TPS
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S116
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2021-07-16
- Decision code
- OK30
- Date received
- 2021-07-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update tooling and work instructions for the assembly of your Micra leadless pacing system.