MitraClip System (NT)
FDA premarket approval P100009/S026 · decided 2018-08-13
Approval details
- PMA number
- P100009
- Supplement
- S026
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- MitraClip System (NT)
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-05-15
- Decision date
- 2018-08-13
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for labeling changes based off the MitraClip Analysis Cohort (MAC) Post Approval Study (PAS).
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