|
Device | CORDIS PCTA DILATATION CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014-5700 |
PMA Number | P880003 |
Supplement Number | S091 |
Date Received | 06/08/2007 |
Decision Date | 07/05/2007 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
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 IN THE ENVIRONMENTAL CONDITIONS OF THE MANUFACTURING FACILITY IN THE FABRICATION OF BALLOONS FOR THE PTCA DILATION CATHETERS. |