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 | RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS |
Generic Name | STENT, CAROTID |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P040012 |
Supplement Number | S010 |
Date Received | 02/28/2006 |
Decision Date | 03/14/2006 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REMOVAL OF STENT MASS AS A FINAL PRODUCT SPECIFICATION FOR THE RX ACCULINK CAROTID STENT SYSTEM AND MODIFICATION OF THE SPECIFICATIONS REGARDING ALLOWABLE CONTAMINANT IN THE DEVICE PACKAGING. |
|
|