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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBlazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP020025
Supplement NumberS138
Date Received03/30/2023
Decision Date04/27/2023
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Use of parametric release and an alternate process challenge device for the BSC2019 ethylene oxide sterilization cycle at the Steris AST Costa Rica Facility.
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