PMA P120016S008

Device
VASCADE VASCULAR CLOSURE SYSTEM
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S008
Product code
MGB
Decision date
2015-01-09
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
ADDITION OF A POUCH SEALER AND ASSOCIATED PROCESSES TO FACILITATE PACKAGING.

Current openFDA PMA Record#

Device
VASCADE VASCULAR CLOSURE SYSTEM
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S008
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2015-01-09
Decision code
OK30
Date received
2014-12-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A POUCH SEALER AND ASSOCIATED PROCESSES TO FACILITATE PACKAGING.