MULTI-LINK VISION & MULTI-LINK MINI VISION CORONARY STENT SYSTEM
FDA premarket approval P020047/S007 · decided 2007-02-09
Approval details
- PMA number
- P020047
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MULTI-LINK VISION & MULTI-LINK MINI VISION CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular
- Date received
- 2006-12-11
- Decision date
- 2007-02-09
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR MINOR MODIFICATIONS TO THE W-CREST PORTION OF BOTH MULTI-LINK VISION STENT SYSTEMS AS WELL AS A NON-LINEAR LINK SHIFT TO THE MEDIUM DESIGN MULTI-LINK VISION CORONARY STENT SYSTEM.
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