PMA P150033S210
- Device
- MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S210
- Product code
- PNJ
- Decision date
- 2025-07-02
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- updating the manufacturing execution system to FACTORYworks Release 10.0 at the Medtronic Swiss Manufacturing Operations facility
Current openFDA PMA Record#
- Device
- MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S210
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-07-02
- Decision code
- OK30
- Date received
- 2025-06-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updating the manufacturing execution system to FACTORYworks Release 10.0 at the Medtronic Swiss Manufacturing Operations facility