|
Device | ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY 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 | S032 |
Date Received | 07/09/1997 |
Decision Date | 06/08/1998 |
Withdrawal Date
|
09/05/2014 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in the biological indicator incubation time from 7 to 5 days. |