PMA P120016S022

Device
VASCADE VASCULAR CLOSURE SYSTEM
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S022
Product code
MGB
Decision date
2017-02-15
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Addition of a new test method, the Distal Outer Sleeve Joint Quality Check.

Current openFDA PMA Record#

Device
VASCADE VASCULAR CLOSURE SYSTEM
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S022
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2017-02-15
Decision code
OK30
Date received
2017-01-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a new test method, the Distal Outer Sleeve Joint Quality Check.