PMA P150033S219
- Device
- Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S219
- Product code
- PNJ
- Decision date
- 2025-12-03
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- an update to the substrate defect mapping process
Current openFDA PMA Record#
- Device
- Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S219
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-12-03
- Decision code
- OK30
- Date received
- 2025-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the substrate defect mapping process