|
Device | FIRE STAR RX PTCA & DURA STAR RX PTCA BALLOON DILATATION CATHETER |
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 | S094 |
Date Received | 02/25/2008 |
Decision Date | 04/15/2008 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES TO THE MANUFACTURING PROCESS TO ADDRESS THE POTENTIAL FOR SLOW OR NO DEFLATION OF THE FIRE STAR RX PTCA BALLOON DILATATION CATHETER AND DURA STAR? RX PTCA BALLOON DILATATION CATHETER. |