PMA P150033S213
- Device
- MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S213
- Product code
- PNJ
- Decision date
- 2025-07-29
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- to add the Micra product line to an existing repack process
Current openFDA PMA Record#
- Device
- MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S213
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-07-29
- Decision code
- OK30
- Date received
- 2025-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add the Micra product line to an existing repack process