PMA P150033S225
- Device
- Micra Transcatheter Pacing System
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S225
- Product code
- PNJ
- Decision date
- 2026-04-22
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- approval of protocol changes for the post-approval study (PAS) referenced above
Current openFDA PMA Record#
- Device
- Micra Transcatheter Pacing System
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S225
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2026-04-22
- Decision code
- APPR
- Date received
- 2026-03-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- approval of protocol changes for the post-approval study (PAS) referenced above