PMA P100009S066
- Device
- MitraClip™ G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S066
- Product code
- NKM
- Decision date
- 2024-07-16
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- reworking and reinforcement of a bond in the delivery catheter handle and modification of downstream leak testing to accommodate the rework
Current openFDA PMA Record#
- Device
- MitraClip™ G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S066
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2024-07-16
- Decision code
- OK30
- Date received
- 2024-06-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reworking and reinforcement of a bond in the delivery catheter handle and modification of downstream leak testing to accommodate the rework