PMA P930038S077

Device: ANGIO-SEAL STS+,ANGIO-SEAL VIP, AND ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICES
Applicant: Terumo Medical Corporation
PMA number: P930038
Supplement: S077
Product code: MGB
Decision date: 2016-04-29
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.

Current openFDA PMA Record#

Device: ANGIO-SEAL STS+,ANGIO-SEAL VIP, AND ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICES
Applicant: Terumo Medical Corporation
PMA number: P930038
Supplement: S077
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2016-04-29
Decision code: APPR
Date received: 2015-08-21
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 St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.