Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P000022 |
Supplement Number | S002 |
Date Received | 11/16/2000 |
Decision Date | 03/15/2001 |
Withdrawal Date
|
12/21/2006 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE POSTAPPROVAL STUDY PROTOCOL FOR THE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM. |
|
|