PMA P150033S147
- Device
- Micra AV TPS, Micra TPS
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S147
- Product code
- PNJ
- Decision date
- 2022-07-26
- Generic name
- Leadless pacemaker
- Approval order statement
- Minor updates to the manufacturing and inspection process at Medtronic’s high-volume manufacturing facility in Galway, Ireland.
Current openFDA PMA Record#
- Device
- Micra AV TPS, Micra TPS
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S147
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2022-07-26
- Decision code
- OK30
- Date received
- 2022-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Minor updates to the manufacturing and inspection process at Medtronic’s high-volume manufacturing facility in Galway, Ireland.