MULTI-LINK RX PIXEL/OTW PIXEL CORONARY STENT SYSTEM
FDA premarket approval P970020/S041 · decided 2002-06-28
Approval details
- PMA number
- P970020
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Trade name
- MULTI-LINK RX PIXEL/OTW PIXEL CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2002-02-15
- Decision date
- 2002-06-28
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR INCLUSION OF SIX-MONTH TRIAL DATA IN THE INSTRUCTIONS FOR USE BOOKLET FOR THE MULTI-LINK RX AND OTW TETRA CORONARY STENT SYSTEMS.
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