|
Device | CORDIS ORION STEERABLE PTCA BALLOON CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | CORDIS CORP. P.O. BOX 025700 MIAMI, FL 33102-5700 |
PMA Number | P890032 |
Supplement Number | S018 |
Date Received | 12/20/1993 |
Decision Date | 08/04/1995 |
Withdrawal Date
|
09/02/2008 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR:ALTERNATE STERILIZATION SITE; ELIMINATION OF CHLOROFLUOROCARBONS FROM THE STERILIZATION PROCESS |