MitraClip NTR/XTR Delivery System
FDA premarket approval P100009/S042 · decided 2021-06-03
Approval details
- PMA number
- P100009
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MitraClip NTR/XTR Delivery System
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-03-31
- Decision date
- 2021-06-03
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval of nitinol gripper line change.
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