PMA P150033S209
- Device
- Micra AV TPS MC1AVR1, Micra AV2 TPS MC2AVR1, Micra TPS MC1VR01, Micra VR2 TPS MC2VR01
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S209
- Product code
- PNJ
- Decision date
- 2025-06-18
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- updates to the mid-process visual inspection criteria for hybrid components
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
- S209
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-06-18
- Decision code
- OK30
- Date received
- 2025-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to the mid-process visual inspection criteria for hybrid components