PMA P100009S073
- Device
- MitraClip Systems
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S073
- Product code
- NKM
- Decision date
- 2025-04-18
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- a change to the manufacturing process for a material component of the delivery system
Current openFDA PMA Record#
- Device
- MitraClip Systems
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S073
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2025-04-18
- Decision code
- OK30
- Date received
- 2025-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the manufacturing process for a material component of the delivery system