PMA P150033S229

Device: Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)
Applicant: Medtronic, Inc.
PMA number: P150033
Supplement: S229
Product code: PNJ
Decision date: 2026-07-31
Classification: Cardiovascular
Generic name: Leadless pacemaker
Approval order statement: to implement additional sub-tier raw material suppliers and other minor process changes for components used in the hybrid subassemblies of Medtronic cardiac rhythm management (CRM) devices.

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: S229
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: to implement additional sub-tier raw material suppliers and other minor process changes for components used in the hybrid subassemblies of Medtronic cardiac rhythm management (CRM) devices.