PMA P100009S071
- Device
- MITRACLIP DELIVERY SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S071
- Product code
- NKM
- Decision date
- 2025-05-09
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- Approval for minor design, material, and manufacturing changes to the Lock Knob Shaft component of the delivery system.
Current openFDA PMA Record#
- Device
- MITRACLIP DELIVERY SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S071
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2025-05-09
- Decision code
- APPR
- Date received
- 2025-02-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design, material, and manufacturing changes to the Lock Knob Shaft component of the delivery system.