PMA P100009S070
- Device
- MitraClip NTR/XTR Clip Delivery System, MitraClip G4 System, MitraClip G5 Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S070
- Product code
- NKM
- Decision date
- 2025-02-10
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- implementation of a PTFE cover as a manufacturing aid during injection molding
Current openFDA PMA Record#
- Device
- MitraClip NTR/XTR Clip Delivery System, MitraClip G4 System, MitraClip G5 Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S070
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2025-02-10
- Decision code
- OK30
- Date received
- 2025-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a PTFE cover as a manufacturing aid during injection molding