PMA P100009S044
- Device
- MitraClip NTR/XTR Clip Delivery System; MitraClip G4 Clip Delivery System (NT, NTW, XT, XTW)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S044
- Product code
- NKM
- Decision date
- 2021-10-22
- Generic name
- Mitral valve repair devices
- Approval order statement
- New cleanroom in an existing facility to manufacture Delivery Catheter sub-assemblies.
Current openFDA PMA Record#
- Device
- MitraClip NTR/XTR Clip Delivery System; MitraClip G4 Clip Delivery System (NT, NTW, XT, XTW)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S044
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2021-10-22
- Decision code
- OK30
- Date received
- 2021-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New cleanroom in an existing facility to manufacture Delivery Catheter sub-assemblies.