PMA P050007S034

Device: STARCLOSE VASCULAR CLOSURE SYSTEM
Applicant: Abbott Vascular Devices
PMA number: P050007
Supplement: S034
Product code: MGB
Decision date: 2016-12-19
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: Reduce the preconditioning time, to eliminate the secondary heated aeration segment of the overall heated aeration phase, and to change the sterilization load configuration.

Current openFDA PMA Record#

Device: STARCLOSE VASCULAR CLOSURE SYSTEM
Applicant: Abbott Vascular Devices
PMA number: P050007
Supplement: S034
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2016-12-19
Decision code: OK30
Date received: 2016-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduce the preconditioning time, to eliminate the secondary heated aeration segment of the overall heated aeration phase, and to change the sterilization load configuration.