MULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM
FDA premarket approval P020047/S004 · decided 2004-09-10
Approval details
- PMA number
- P020047
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular
- Date received
- 2004-05-17
- Decision date
- 2004-09-10
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE 2.75 MM LINE EXTENSION FOR THE MULTI-LINK VISION CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE WITH FAILED INTERVENTIONAL THERAPY OF DE NOVO AND RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.75 MM.
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