PMA P100009S032
- Device
- MitraClip NT, NTR, and XTR Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S032
- Product code
- NKM
- Decision date
- 2019-07-18
- Classification
- Mitral Valve Repair Devices
- Generic name
- Mitral valve repair devices
- Approval order statement
- Use of an additional alternative Bacterial Endotoxin testing laboratory for the MitraClip NTR/XTR and G4 devices.
Current openFDA PMA Record#
- Device
- MitraClip NT, NTR, and XTR Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S032
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2019-07-18
- Decision code
- OK30
- Date received
- 2019-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an additional alternative Bacterial Endotoxin testing laboratory for the MitraClip NTR/XTR and G4 devices.