PMA P120016S018

Device
VASCADE VASCULAR CLOSURE SYSTEM
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S018
Product code
MGB
Decision date
2015-12-14
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
REMOVAL OF THE COLLAGEN COMPRESSION STEP AND INCOMING INSPECTION COLLAGEN HYDRATION TEST.

Current openFDA PMA Record#

Device
VASCADE VASCULAR CLOSURE SYSTEM
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S018
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2015-12-14
Decision code
OK30
Date received
2015-11-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REMOVAL OF THE COLLAGEN COMPRESSION STEP AND INCOMING INSPECTION COLLAGEN HYDRATION TEST.