PMA P040038S018

Device: XACT CAROTID STENT SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P040038
Supplement: S018
Product code: NIM
Decision date: 2009-05-07
Classification: Stent, Carotid
Generic name: Stent, carotid
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR CORPORATION, TEMECULA, CALIFORNIA, AND A STERILIZATION SITE LOCATED AT STERIGENICS, LOS ANGELES, CALIFORNIA.

Current openFDA PMA Record#

Device: XACT CAROTID STENT SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P040038
Supplement: S018
Product code: NIM
Generic name: Stent, carotid
Decision date: 2009-05-07
Decision code: APPR
Date received: 2009-02-13
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR CORPORATION, TEMECULA, CALIFORNIA, AND A STERILIZATION SITE LOCATED AT STERIGENICS, LOS ANGELES, CALIFORNIA.