MULTI-LINK 8 SMALL VESSEL CORONARY STENT SYSTEM
FDA premarket approval P020047/S022 · decided 2010-08-31
Approval details
- PMA number
- P020047
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MULTI-LINK 8 SMALL VESSEL CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular
- Date received
- 2010-07-01
- Decision date
- 2010-08-31
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE 2.25MM DIAMETER STENT SIZE AS PART OF THE MULTI-LINK 8 CORONARY STENT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MULTI-LINK 8 SV CORONARY STENT SYSTEM AND IS INDICATED FOR 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 2.25MM.
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