PMA P150033S222
- Device
- Miera AV TPS; Miera TPS
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S222
- Product code
- PNJ
- Decision date
- 2026-02-23
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- implementing an updated software package for automated visual inspection system
Current openFDA PMA Record#
- Device
- Miera AV TPS; Miera TPS
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S222
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2026-02-23
- Decision code
- OK30
- Date received
- 2026-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementing an updated software package for automated visual inspection system