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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 OPEN-IRRIGATED ABLATION CATHETER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific Corp
4100 Hamline Ave. N.
Alternate Contact, MN 55112
PMA NumberP150005
Supplement NumberS005
Date Received04/11/2016
Decision Date07/07/2016
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for design changes to incorporate a magnetic sensor into the Blazer Open Irrigated Ablation Catheter. The device, as modified, will be marketed under the trade name IntellaNav Open-Irrigated Ablation Catheter and is indicated for: The IntellaNav™ Open-Irrigated Catheter, when used with a Maestro 4000® Radiofrequency (RF) Controller and MetriQ™ Irrigation Pump, is indicated for:1) cardiac electrophysiological mapping; 2) delivering diagnostic pacing stimuli; and 3) RF ablation of sustained or recurrent type 1 atrial flutter in patients age 18 years or older.
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