CORDIS CHECKMATE SYSTEM
FDA premarket approval P990036/S003 · decided 2002-07-25
Approval details
- PMA number
- P990036
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CORDIS CHECKMATE SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Cordis Corp.
- Date received
- 2002-06-10
- Decision date
- 2002-07-25
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE REGARDING THE RECOILING OF THE SOURCE RIBBON ON THE SPOOL OF THE DELIVERY DEVICE AND THE USE OF THE METAL CAPS ON THE ENDS OF THE DELIVERY DEVICE.
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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 |