PMA P000018S043

Device
BETA-CATH SYSTEM
Applicant
Best Vascular, Inc.
PMA number
P000018
Supplement
S043
Product code
MOU
Decision date
2008-11-19
Classification
Intravascular Radiation Delivery System
Generic name
Intravascular radiation delivery system
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
BETA-CATH SYSTEM
Applicant
Best Vascular, Inc.
PMA number
P000018
Supplement
S043
Product code
MOU
Generic name
Intravascular radiation delivery system
Decision date
2008-11-19
Decision code
APPR
Date received
2006-11-28
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.