PMA P100009S043
- Device
- MitraClip NTR/XTR System, MitraClip G4System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S043
- Product code
- NKM
- Decision date
- 2021-08-01
- Generic name
- Mitral valve repair devices
- Approval order statement
- Use of two new heated dryers to manufacture the MitraClip NTR/XTR and G4 Systems.
Current openFDA PMA Record#
- Device
- MitraClip NTR/XTR System, MitraClip G4System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S043
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2021-08-01
- Decision code
- OK30
- Date received
- 2021-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of two new heated dryers to manufacture the MitraClip NTR/XTR and G4 Systems.