PMA P050007S032

Device
STARCLOSE SE VASCULAR CLOSURE SYSTEM
Applicant
Abbott Vascular Devices
PMA number
P050007
Supplement
S032
Product code
MGB
Decision date
2014-10-10
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
MODIFIED CLEANING PROCESS FOR THE CLIP SUBASSEMBLY.

Current openFDA PMA Record#

Device
STARCLOSE SE VASCULAR CLOSURE SYSTEM
Applicant
Abbott Vascular Devices
PMA number
P050007
Supplement
S032
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2014-10-10
Decision code
OK30
Date received
2014-09-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MODIFIED CLEANING PROCESS FOR THE CLIP SUBASSEMBLY.