PMA P120016S006

Device: VASCADE VASCULAR CLOSURE SYSTEM
Applicant: Cardiva Medical, Inc.
PMA number: P120016
Supplement: S006
Product code: MGB
Decision date: 2014-10-23
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: REORGANIZATION OF TWO EXISTING MANUFACTURING STEPS AND A CHANGE OF LOCATION OF THE PROCESSES TO BE PERFORMED TO OUTSIDE OF A CONTROLLED ENVIRONMENT ROOM (CER).

Current openFDA PMA Record#

Device: VASCADE VASCULAR CLOSURE SYSTEM
Applicant: Cardiva Medical, Inc.
PMA number: P120016
Supplement: S006
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2014-10-23
Decision code: OK30
Date received: 2014-09-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REORGANIZATION OF TWO EXISTING MANUFACTURING STEPS AND A CHANGE OF LOCATION OF THE PROCESSES TO BE PERFORMED TO OUTSIDE OF A CONTROLLED ENVIRONMENT ROOM (CER).