PMA P000020

Device
BARD ABLATION SYSTEM
Applicant
Boston Scientific Corp
PMA number
P000020
Supplement
S017
Product code
LPB
Decision date
2014-06-04
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
APPROVAL FOR IMPLEMENTATION OF A CHANGE TO LEAD-FREE SOLDER IN THECONNECTOR COMPONENT OF THE STINGER AND SCORPION2 ABLATION CATHETERS.

Current openFDA PMA Record#

Device
BARD ABLATION SYSTEM
Applicant
Boston Scientific Corp
PMA number
P000020
Supplement
S017
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2014-06-04
Decision code
APPR
Date received
2014-04-17
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR IMPLEMENTATION OF A CHANGE TO LEAD-FREE SOLDER IN THECONNECTOR COMPONENT OF THE STINGER AND SCORPION2 ABLATION CATHETERS.