ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM
FDA premarket approval P970020/S035 · decided 2002-01-14
Approval details
- PMA number
- P970020
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2001-08-06
- Decision date
- 2002-01-14
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ADDITION OF AN INDICATION TO USE THE 4.5 MM AND 5.0 MM ULTRA OTW AND RX FOR THE TREATMENT OF SAPHENOUS VEIN GRAFT (SVG) LESIONS. THE MULTI-LINK RX ULTRA AND MULTI-LINK OTW ULTRA CORONARY STENT SYSTEM WILL INCLUDE THE FOLLOWING INDICATION: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENCE VESSEL EIAMETERS RANGING FROM 3.5 MM TO 5.0 MM; 2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART
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