MITRACLIP CLIP DELIVERY SYSTEM
FDA premarket approval P100009/S005 · decided 2014-05-22
Approval details
- PMA number
- P100009
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MITRACLIP CLIP DELIVERY SYSTEM
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-05-01
- Decision date
- 2014-05-22
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR A LABELING CHANGE THAT INCLUDED ADDITIONS TO THE LIST OF ANTICIPATED EVENTS AND CONVERTING CERTAIN PROCEDURAL CAUTION STATEMENTS TO WARNING STATEMENTS.
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