MitraClip System (NTR and XTR)
FDA premarket approval P100009/S025 · decided 2018-05-23
Approval details
- PMA number
- P100009
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MitraClip System (NTR and XTR)
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-10-24
- Decision date
- 2018-05-23
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for several design and manufacturing changes to the clip delivery system and implant as well as minor changes to device packaging.
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