PMA P100009S047
- Device
- MitraClip™ Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S047
- Product code
- NKM
- Decision date
- 2022-09-09
- Generic name
- Mitral valve repair devices
- Approval order statement
- increased sterilization capacity for the MitraClip Clip Delivery System through increase in capacity of an existing chamber and addition of a new chamber
Current openFDA PMA Record#
- Device
- MitraClip™ Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S047
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2022-09-09
- Decision code
- OK30
- Date received
- 2022-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- increased sterilization capacity for the MitraClip Clip Delivery System through increase in capacity of an existing chamber and addition of a new chamber