PMA P150033S217
- Device
- Micra Transcatheter Pacing Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S217
- Product code
- PNJ
- Decision date
- 2025-11-25
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- approval for labeling updates to reflect the results of the Micra Jugular Access PAS
Current openFDA PMA Record#
- Device
- Micra Transcatheter Pacing Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S217
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-11-25
- Decision code
- APPR
- Date received
- 2025-08-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- approval for labeling updates to reflect the results of the Micra Jugular Access PAS