ACS MULTI-LINK RX DUET TM AND ACS MULTI-LINK OTW DUET TM CORONARY STENT SYSTEMS
FDA premarket approval P970020/S004 · decided 1998-11-05
Approval details
- PMA number
- P970020
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS MULTI-LINK RX DUET TM AND ACS MULTI-LINK OTW DUET TM CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1998-05-14
- Decision date
- 1998-11-05
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for the ACS Multi-Link RX Duet(TM) and ACS Multi-Link OTW Duet(TM) Coronary Stent Systems. These devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic lesions in native coronary arteries (length < 25mm) with a reference vessel diameter ranging from 3.0 mm to 4.0 mm.
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