MITRACLIP NT CLIP DELIVERY SYSTEM
FDA premarket approval P100009/S015 · decided 2016-05-10
Approval details
- PMA number
- P100009
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MITRACLIP NT CLIP DELIVERY SYSTEM
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-10-01
- Decision date
- 2016-05-10
- Days to decision
- 222 days
- Decision code
- APPR
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for a material change to the gripper, design and manufacturing changes to the delivery system, and changes to device packaging.
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