BX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM
FDA premarket approval P900043/S028 · decided 2001-09-21
Approval details
- PMA number
- P900043
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Cordis Corp.
- Date received
- 2001-04-06
- Decision date
- 2001-09-21
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A NEW INDICATION (ELECTIVE STENTING OF DE NOVO AND RESTENOTIC CORONARY ARTERIES) AND ADDITIONAL STENT DIAMETERS (4.5 AND 5.0 MM) FOR THE BX VELOCITY WITH HEPACOAT ON STENT SYSTEM. THE DEVICE, AS MODIFIED, IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (= 30 MM IN LENGTH IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 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 |