PMA P040038S048

Device: XACT® Carotid Stent System
Applicant: Abbott Vascular, Inc.
PMA number: P040038
Supplement: S048
Product code: NIM
Decision date: 2025-12-09
Classification: Cardiovascular
Generic name: Stent, carotid
Approval order statement: approval for a manufacturing site located at Synergy Health AST, SRL, B13.1 Street 4, Avenue 1, Coyol Free Zone, Coyol, Alajuela, 20102, Costa Rica for sterilization.

Current openFDA PMA Record#

Device: XACT® Carotid Stent System
Applicant: Abbott Vascular, Inc.
PMA number: P040038
Supplement: S048
Product code: NIM
Generic name: Stent, carotid
Decision date: 2025-12-09
Decision code: APPR
Date received: 2025-05-12
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 Synergy Health AST, SRL, B13.1 Street 4, Avenue 1, Coyol Free Zone, Coyol, Alajuela, 20102, Costa Rica for sterilization.