PMA P000020S017

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.

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