PMA P100009S038
- Device
- MitraClip Clip System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S038
- Product code
- NKM
- Decision date
- 2021-02-22
- Generic name
- Mitral valve repair devices
- Approval order statement
- Minor manufacturing changes to the gripper line of the Clip Delivery System.
Current openFDA PMA Record#
- Device
- MitraClip Clip System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S038
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2021-02-22
- Decision code
- OK30
- Date received
- 2021-01-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Minor manufacturing changes to the gripper line of the Clip Delivery System.