PMA P020025S038

Device
EPT-1000 XP RF ABLATION SYSTEM
Applicant
Boston Scientific
PMA number
P020025
Supplement
S038
Product code
OAD
Decision date
2013-02-22
Classification
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement
AUTOMATE THE TEMPERATURE, HUMIDITY, AND DIFFERENTIAL PRESSURE MONITORING SYSTEM AT THE HEREDIA, COSTA RICA FACILITY.
Summary
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Current openFDA PMA Record#

Device
EPT-1000 XP RF ABLATION SYSTEM
Applicant
Boston Scientific
PMA number
P020025
Supplement
S038
Product code
OAD
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date
2013-02-22
Decision code
OK30
Date received
2013-01-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
AUTOMATE THE TEMPERATURE, HUMIDITY, AND DIFFERENTIAL PRESSURE MONITORING SYSTEM AT THE HEREDIA, COSTA RICA FACILITY.