ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM
FDA premarket approval P970020/S003 · decided 1998-11-24
Approval details
- PMA number
- P970020
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1998-05-11
- Decision date
- 1998-11-24
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for a change in the Mean Stent Compliance Outer Diameter specification, associated with the ACS RX Multi-Link HP(TM) and ACS OTW Multi-Link HP(TM) Coronary Stents Systems.
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