|
Device | SIMPSON CORONARY ATHEROCATH-GTO |
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 | S034 |
Date Received | 09/13/1999 |
Decision Date | 10/12/1999 |
Withdrawal Date
|
09/05/2014 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The 30-Day Notice requested implementation of two additional on-line inspections to the current manufacturing process to provide added assurance that the manufacturing step for attaching the nose cone to the housing has been performed correctly. |