CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM)
FDA premarket approval P020026/S026 · decided 2011-02-22
Approval details
- PMA number
- P020026
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM)
- Generic name
- Coronary drug-eluting stent
- Applicant
- Cordis Corp.
- Date received
- 2006-07-25
- Decision date
- 2011-02-22
- Days to decision
- 1673 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- APPROVAL FOR THE 4.0MM CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTORRAIL (RX) DELIVERY SYSTEM. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME 4.00MM CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS OF LENGTH <= 30 MM IN NATIVE CORONARY ARTERIES WITH A REFERENCE VESSEL DIAMETER OF >= 2.25 TO <= 4.0 MM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM (K130981) | Cordis Corp. | 2014-03-12 |
| POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (K112797) | Cordis Corp. | 2012-05-04 |
| ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE (K101651) | Cordis Corp. | 2010-07-09 |
| MICRO GUIDE CATHETER XP (K082143) | Cordis Corp. | 2008-08-25 |
| SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB (K062798) | Cordis Corp. | 2008-02-06 |
| PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX (K060877) | Cordis Corp. | 2006-04-27 |
| CORDIS AMIIA .014 PTA BALLOON CATHETER (K050645) | Cordis Corp. | 2005-04-01 |
| CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE (K040592) | Cordis Corp. | 2004-12-17 |