PMA P100009S033
- Device
- MitraClip XTR Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S033
- Product code
- NKM
- Decision date
- 2019-07-26
- Classification
- Mitral Valve Repair Devices
- Generic name
- Mitral valve repair devices
- Approval order statement
- Approval for a reduction in the upper tolerance limit of the MitraClip arm tip-to-tip dimension.
Current openFDA PMA Record#
- Device
- MitraClip XTR Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S033
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2019-07-26
- Decision code
- APPR
- Date received
- 2019-06-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a reduction in the upper tolerance limit of the MitraClip arm tip-to-tip dimension.