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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.
 
DeviceIntellaNav MiFi Open-Irrigated Ablation Catheter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150005
Supplement NumberS054
Date Received04/30/2020
Decision Date05/29/2020
Product Code OAD 
Advisory Committee Cardiovascular
Clinical TrialsNCT03232645
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the final protocol and analysis plan for the post-approval study (PAS) protocol.
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