PMA P150033S223

Device: Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)
Applicant: Medtronic, Inc.
PMA number: P150033
Supplement: S223
Product code: PNJ
Decision date: 2026-04-30
Classification: Cardiovascular
Generic name: Leadless pacemaker
Approval order statement: Approval for updates to the manufacturing acceptance conditions for plated through holes in hybrid subassemblies incorporated into implantable cardiac rhythm management 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: S223
Product code: PNJ
Generic name: Leadless pacemaker
Decision date: 2026-04-30
Decision code: APPR
Date received: 2026-01-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updates to the manufacturing acceptance conditions for plated through holes in hybrid subassemblies incorporated into implantable cardiac rhythm management devices.