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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 STABLEPOINT™ 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 NumberS084
Date Received04/02/2024
Decision Date06/25/2024
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for manufacturing, supplier, and design changes to the Micro Inductive Position Sensor (MIPS), used in the IntellaNav StablePoint catheter
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