PMA P150033S084
- Device
- Micra AV TPS and Micra TPS
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S084
- Product code
- PNJ
- Decision date
- 2020-08-27
- Generic name
- Leadless pacemaker
- Approval order statement
- Update Micra battery weld inspection requirements to remove conflicting tether-pin weld rejection criterion.
Current openFDA PMA Record#
- Device
- Micra AV TPS and Micra TPS
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S084
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2020-08-27
- Decision code
- OK30
- Date received
- 2020-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update Micra battery weld inspection requirements to remove conflicting tether-pin weld rejection criterion.