|
Device | FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | ABBOTT VASCULAR 26531 YNEZ ROAD BUILDING G MAILING P.O. 9018 TEMECULA, CA 92590 |
PMA Number | P890043 |
Supplement Number | S039 |
Date Received | 11/06/2006 |
Decision Date | 12/11/2006 |
Withdrawal Date
|
09/05/2014 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIGENICS, SANTA TERESA, NEW MEXICO. |