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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.
 
DeviceOpal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150005
Supplement NumberS088
Date Received07/03/2025
Decision Date09/02/2025
Product Codes OAD OAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
brand name changes for Ablation Connection Boxes to reflect a new electrophysiology mapping system brand name (RHYTHMIA HDx Mapping System to OPAL HDx Mapping System)
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