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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 Open Irrigated Ablation Catheter, IntellaNav Open Irrigated Ablation Catheter, IntellaNav MiFi Open Irrigated Abl
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150005
Supplement NumberS086
Date Received08/16/2024
Decision Date11/14/2024
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a change in the adhesive used in the proximal extension tube to female luer lock adhesive joint, a new product specification, and modifications to manufacturing processes
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