ACS MULTI-LINK RX DUET (TM)/ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS
FDA premarket approval P970020/S024 · decided 2000-06-23
Approval details
- PMA number
- P970020
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS MULTI-LINK RX DUET (TM)/ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2000-05-30
- Decision date
- 2000-06-23
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR INCLUSION OF THE SIX-MONTH CLINICAL TRIAL DATA FROM THE DUET STUDY IN THE INSTRUCTIONS FOR USE (IFU) FOR THE ACS MULTI-LINK RX AND OTW DUET(TM) CORONARY STENT SYSTEMS.
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