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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 Filter Module and IntellaTip MiFi Reference Cable
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP020025
Supplement NumberS130
Date Received03/11/2021
Decision Date04/08/2021
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Boston Scientific Corporation, 4100 Hamline Avenue North, Saint Paul, Minnesota, for the manufacturing, distribution, and warehousing activities for the IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable.
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