PMA P150033S098
- Device
- Micra Transcatheter Pacemaker System
- Applicant
- Medtronic, Inc.
- Product code
- PNJ
- Decision date
- 2022-07-15
- Generic name
- Leadless pacemaker
- Approval order statement
- Approval for the introduction of the Optimized PCA Sterilization Cycle
Current openFDA PMA Record#
- Device
- Micra Transcatheter Pacemaker System
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S098
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2022-07-15
- Decision code
- APPR
- Date received
- 2021-03-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the introduction of the Optimized PCA Sterilization Cycle