FIRESTAR RX PTCA BALLOON DILATATION CATHETER AND DURASTAR RX PTCA BALLOON DILATATION CATHETER
FDA premarket approval P880003/S098 · decided 2009-08-13
Approval details
- PMA number
- P880003
- Supplement
- S098
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FIRESTAR RX PTCA BALLOON DILATATION CATHETER AND DURASTAR RX PTCA BALLOON DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Cordis Corp.
- Date received
- 2009-07-30
- Decision date
- 2009-08-13
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE MODIFICATION OF A CAUTION STATEMENT IN THE IFU FO THE DEVICE.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |