PMA P000018S009

Device
NOVOSTE BETA-CATH SYSTEM
Applicant
Best Vascular, Inc.
PMA number
P000018
Supplement
S009
Product code
MOU
Decision date
2001-10-26
Classification
Intravascular Radiation Delivery System
Generic name
Intravascular radiation delivery system
Approval order statement
APPROVAL FOR THE REVISED SOURCE SEED SPECIFICATION (2.7 - 40 MCI) FOR THE BETA-CATH SYSTEM.

Current openFDA PMA Record#

Device
NOVOSTE BETA-CATH SYSTEM
Applicant
Best Vascular, Inc.
PMA number
P000018
Supplement
S009
Product code
MOU
Generic name
Intravascular radiation delivery system
Decision date
2001-10-26
Decision code
APPR
Date received
2001-02-12
Supplement type
Normal 180 Day Track
Supplement reason
Other
Approval order statement
APPROVAL FOR THE REVISED SOURCE SEED SPECIFICATION (2.7 - 40 MCI) FOR THE BETA-CATH SYSTEM.