PMA P020025S059

Device
MAESTRO 3000 CARDIAC ABLATION SYSTEM
Applicant
Boston Scientific
PMA number
P020025
Supplement
S059
Product code
OAD
Decision date
2014-10-17
Classification
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA.
Summary
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Current openFDA PMA Record#

Device
MAESTRO 3000 CARDIAC ABLATION SYSTEM
Applicant
Boston Scientific
PMA number
P020025
Supplement
S059
Product code
OAD
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date
2014-10-17
Decision code
APPR
Date received
2014-05-05
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA.