PMA P100009S030
- Device
- MitraClip System (NTR and XTR)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S030
- Product code
- NKM
- Decision date
- 2019-06-03
- Classification
- Mitral Valve Repair Devices
- Generic name
- Mitral valve repair devices
- Approval order statement
- Approval for an update to the Instructions for Use to clarify correct device use.
Current openFDA PMA Record#
- Device
- MitraClip System (NTR and XTR)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S030
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2019-06-03
- Decision code
- APPR
- Date received
- 2019-05-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an update to the Instructions for Use to clarify correct device use.