PMA P000018S034

Device
NOVOSTE BETA-CATH SYSTEM
Applicant
Best Vascular, Inc.
PMA number
P000018
Supplement
S034
Product code
MOU
Decision date
2003-06-25
Classification
Intravascular Radiation Delivery System
Generic name
Intravascular radiation delivery system
Approval order statement
CHANGE OF ADDITIONAL PROGRAMMING AND USE OF A REWORKED PRINTED CIRCUIT BOARD ASSEMBLY.

Current openFDA PMA Record#

Device
NOVOSTE BETA-CATH SYSTEM
Applicant
Best Vascular, Inc.
PMA number
P000018
Supplement
S034
Product code
MOU
Generic name
Intravascular radiation delivery system
Decision date
2003-06-25
Decision code
OK30
Date received
2003-05-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE OF ADDITIONAL PROGRAMMING AND USE OF A REWORKED PRINTED CIRCUIT BOARD ASSEMBLY.