|
Device | XACT CAROTID STENT SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | ABBOTT VASCULAR INC. 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P040038 |
Supplement Number | S013 |
Date Received | 06/09/2008 |
Decision Date | 11/10/2008 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MOVE THE XACT MANUFACTURING PROCESSES WITHIN THE EXISTING MANUFACTURING FACILITY AND TO MOVE TWO PIECES OF DUPLICATE MANUFACTURING EQUIPMENT FROM ONE BUILDING TO ANOTHER. |