MitraClip NTR/XTR Clip Delivery System and Steerable Guide Catheter
FDA premarket approval P100009/S031 · decided 2019-07-26
Approval details
- PMA number
- P100009
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MitraClip NTR/XTR Clip Delivery System and Steerable Guide Catheter
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-05-29
- Decision date
- 2019-07-26
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval of the protocol for the post-approval study entitled "Registry-Based Continued Access Protocol Cohort and Real-World Use Surveillances."
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