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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 | S043 |
Date Received | 06/27/2023 |
Decision Date | 02/07/2024 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement the expansion of the indications to include use of the XACT Carotid Stent System in conjunction with the ENROUTE NPS device during Transcarotid Artery Revascularization (TCAR) procedures |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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