|
Device | CORDIS CHECKMATE(TM) SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014 |
PMA Number | P990036 |
Date Received | 07/01/1999 |
Decision Date | 11/03/2000 |
Withdrawal Date
|
11/15/2007 |
Product Code |
MOU |
Docket Number | 00M-1650 |
Notice Date | 12/13/2000 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CORDIS CHECKMATE(TM) SYSTEM. THE DEVICE IS INDICATED FOR THE DELIVERY OF THERAPEUTIC DOSES OF GAMMA RADIATION FOR THE PURPOSE OF REDUCING IN-STENT RESTENOSIS. THE SYSTEM IS FOR USE IN THE TREATMENT OF NATIVE CORONARY ARTERIES (2.75 - 4.0 MM IN DIAMETER AND LESIONS UP TO AND INCLUDING 45 MM IN LENGTH) WITH IN-STENT RESTENOSIS FOLLOWING PERCUTANEOUS REVASCULARIZATION USING CURRENT INTERVENTIONAL TECHNIQUES. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 |