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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.
 
DeviceIntellaTip MiFi OI, IntellaNav MiFi OI, IntellaNav OI, Blazer OI
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP150005
Supplement NumberS068
Date Received11/10/2021
Decision Date12/10/2021
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of a new piece of equipment at the supplier to automate the current manual process used to decore the braided subassembly.
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