|
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 |
Supplement Number | S002 |
Date Received | 06/28/2001 |
Decision Date | 07/27/2001 |
Withdrawal Date
|
11/15/2007 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE MANUFACTURING PROCESSING AND COLORANT OF THE UNI-DUMMY RIBBON ASSEMBLY TO THE CHECKMATE SYSTEM. |