PMA P150033S218
- Device
- Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01)
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S218
- Product code
- PNJ
- Decision date
- 2025-12-02
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- to expand energy windows used for two laser solder equipment units used in manufacturing Micra Pacemaker Devices
Current openFDA PMA Record#
- Device
- Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01)
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S218
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-12-02
- Decision code
- OK30
- Date received
- 2025-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to expand energy windows used for two laser solder equipment units used in manufacturing Micra Pacemaker Devices