PMA P150033S221

Device: Micra Transcatheter Pacing System (MC1VR01), Micra AV Transcatheter Pacing System (MC1AVR1), Micra VR2 Transcatheter Pac
Applicant: Medtronic, Inc.
PMA number: P150033
Supplement: S221
Product code: PNJ
Decision date: 2026-02-11
Classification: Cardiovascular
Generic name: Leadless pacemaker
Approval order statement: an additional, alternative external Process Challenge Device (ePCD) for routine monitoring of the ethylene-oxide-sterilization process and reduction the incubation time of the proposed ePCD from the standard 7 days to 4 days

Current openFDA PMA Record#

Device: Micra Transcatheter Pacing System (MC1VR01), Micra AV Transcatheter Pacing System (MC1AVR1), Micra VR2 Transcatheter Pac
Applicant: Medtronic, Inc.
PMA number: P150033
Supplement: S221
Product code: PNJ
Generic name: Leadless pacemaker
Decision date: 2026-02-11
Decision code: OK30
Date received: 2026-01-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an additional, alternative external Process Challenge Device (ePCD) for routine monitoring of the ethylene-oxide-sterilization process and reduction the incubation time of the proposed ePCD from the standard 7 days to 4 days