PMA P100009S072
- Device
- MitraClip G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S072
- Product code
- NKM
- Decision date
- 2025-05-06
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- an increase in the maximum occupancy in the production room and gowning room in a specified cleanroom
Current openFDA PMA Record#
- Device
- MitraClip G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S072
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2025-05-06
- Decision code
- OK30
- Date received
- 2025-04-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an increase in the maximum occupancy in the production room and gowning room in a specified cleanroom