CYPHER SIROLIMUS-ELUTING CORONARY STENTS ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM
FDA premarket approval P020026/S030 · decided 2007-01-10
Approval details
- PMA number
- P020026
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CYPHER SIROLIMUS-ELUTING CORONARY STENTS ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Cordis Corp.
- Date received
- 2006-10-31
- Decision date
- 2007-01-10
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- APPROVAL FOR A PROCESS ENHANCER FOR AN ADHESIVE USED IN CONSTRUCTION OF THE DELIVERY SYSTEM.
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| PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX (K060877) | Cordis Corp. | 2006-04-27 |
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| CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE (K040592) | Cordis Corp. | 2004-12-17 |