PMA P000018S038

Device
NOVOSTE BETA-CATH SYSTEM
Applicant
Best Vascular, Inc.
PMA number
P000018
Supplement
S038
Product code
MOU
Decision date
2003-10-14
Classification
Intravascular Radiation Delivery System
Generic name
Intravascular radiation delivery system
Approval order statement
CHANGE IN THE SUPPLIERS OF TWO COMPONENTS USED IN THE ROUTINE MAINTENANCE AND SERVING OF THE ALPHA TRANSFER DEVICES.

Current openFDA PMA Record#

Device
NOVOSTE BETA-CATH SYSTEM
Applicant
Best Vascular, Inc.
PMA number
P000018
Supplement
S038
Product code
MOU
Generic name
Intravascular radiation delivery system
Decision date
2003-10-14
Decision code
OK30
Date received
2003-10-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE SUPPLIERS OF TWO COMPONENTS USED IN THE ROUTINE MAINTENANCE AND SERVING OF THE ALPHA TRANSFER DEVICES.