PMA P100009S045
- Device
- MitraClip™ G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S045
- Product code
- NKM
- Decision date
- 2022-08-08
- Generic name
- Mitral valve repair devices
- Approval order statement
- Approval for the addition of a manufacturing site located at 1820 Bastian Court, Westfield, Indiana, 46074.
Current openFDA PMA Record#
- Device
- MitraClip™ G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S045
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2022-08-08
- Decision code
- APPR
- Date received
- 2022-01-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a manufacturing site located at 1820 Bastian Court, Westfield, Indiana, 46074.