PMA P150033S228
- Device
- Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S228
- Product code
- PNJ
- Decision date
- 2026-07-31
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- changes to cleaning process and revising acceptance criteria for final visual inspection of hybrid subassembly
Current openFDA PMA Record#
- Device
- Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S228
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2026-07-31
- Decision code
- OK30
- Date received
- 2026-07-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to cleaning process and revising acceptance criteria for final visual inspection of hybrid subassembly