PMA P920047S067

Device
BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS
Applicant
Boston Scientific Corp
PMA number
P920047
Supplement
S067
Product code
LPB
Decision date
2014-04-04
Classification
Cardiac Ablation Percutaneous Catheter
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
ACCEPTANCE FOR BIOBURDEN TESTING TO BE COMPLETED AT AN ALTERNATE FACILITY
Summary
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Current openFDA PMA Record#

Device
BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS
Applicant
Boston Scientific Corp
PMA number
P920047
Supplement
S067
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2014-04-04
Decision code
OK30
Date received
2014-03-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ACCEPTANCE FOR BIOBURDEN TESTING TO BE COMPLETED AT AN ALTERNATE FACILITY