PMA P150033S216
- Device
- Miera AV TPS (MC1AVR1); Miera A V2 TPS (MC2AVR1); Miera TPS (MC1VR01); Miera VR2 TPS (MC2VR01)
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S216
- Product code
- PNJ
- Decision date
- 2025-09-05
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- implementation of a new visual inspection procedure
Current openFDA PMA Record#
- Device
- Miera AV TPS (MC1AVR1); Miera A V2 TPS (MC2AVR1); Miera TPS (MC1VR01); Miera VR2 TPS (MC2VR01)
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S216
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-09-05
- Decision code
- OK30
- Date received
- 2025-08-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a new visual inspection procedure