PMA P100009S035
- Device
- MitraClip NTR, XTR and G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S035
- Product code
- NKM
- Decision date
- 2019-09-11
- Classification
- Mitral Valve Repair Devices
- Generic name
- Mitral valve repair devices
- Approval order statement
- Several modifications to component suppliers, test methods, and inspections.
Current openFDA PMA Record#
- Device
- MitraClip NTR, XTR and G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S035
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2019-09-11
- Decision code
- OK30
- Date received
- 2019-08-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Several modifications to component suppliers, test methods, and inspections.