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. |
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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 | S006 |
Date Received | 07/10/2006 |
Decision Date | 11/21/2006 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO 1) TIGHTEN THE CONNECTOR INNER DIAMETER SPECIFICATION TOLERANCE; AND 2) MODIFY THE STENT HEAT TREATMENT PROCESS. |
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