PMA P000018S014

Device
BETA-CATH(TM) SYSTEM
Applicant
Best Vascular, Inc.
PMA number
P000018
Supplement
S014
Product code
MOU
Decision date
2001-07-13
Classification
Intravascular Radiation Delivery System
Generic name
Intravascular radiation delivery system
Approval order statement
CHANGE IN THE STERILIZATION PROCESS.

Current openFDA PMA Record#

Device
BETA-CATH(TM) SYSTEM
Applicant
Best Vascular, Inc.
PMA number
P000018
Supplement
S014
Product code
MOU
Generic name
Intravascular radiation delivery system
Decision date
2001-07-13
Decision code
OK30
Date received
2001-06-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE STERILIZATION PROCESS.