|
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 | S035 |
Date Received | 03/06/2000 |
Decision Date | 04/06/2001 |
Withdrawal Date
|
09/05/2014 |
Product Code |
MCX |
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 THE FLEXI-CUT(TM) DIRECTION DEBULKING SYSTEM. THE FLEXI-CUT(TM) DIRECTION DEBULKING SYSTEM IS INDICATED FOR USE IN CORONARY ARTERY DISEASE ACCESSIBLE TO DCA (DIRECTIONAL CORONARY ATHERECTOMY), GENERALLY IN THE PROXIMAL OR MID-PORTION OF CORONARY VESSELS. IT CAN BE USED ALONE OR IN CONJUNCTION WITH OTHER CORONARY INTERVENTIONAL DEVICES. DCA IS INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER BY MECHANICALLY SHAVING AND REMOVING ATHEROSCLEROTIC MATERIAL FROM THE DISEASED VESSEL. |