PMA P100009S050
- Device
- MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S050
- Product code
- NKM
- Decision date
- 2022-12-15
- Generic name
- Mitral valve repair devices
- Approval order statement
- Changes to adhesives used in the MitraClip Clip Delivery System.
Current openFDA PMA Record#
- Device
- MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S050
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2022-12-15
- Decision code
- OK30
- Date received
- 2022-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to adhesives used in the MitraClip Clip Delivery System.