PMA P120016S012

Device
VASCADE VASCULAR CLOSURE SYSTEM
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S012
Product code
MGB
Decision date
2015-03-31
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
TRANSFER OF THE EPOXY BRAID TO SHAFT SUBASSEMBLY TO A NEW MANUFACTURING LOCATION.

Current openFDA PMA Record#

Device
VASCADE VASCULAR CLOSURE SYSTEM
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S012
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2015-03-31
Decision code
OK30
Date received
2015-03-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
TRANSFER OF THE EPOXY BRAID TO SHAFT SUBASSEMBLY TO A NEW MANUFACTURING LOCATION.