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. |
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Device | IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BOSTON SCIENTIFIC 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P020025 |
Supplement Number | S130 |
Date Received | 03/11/2021 |
Decision Date | 04/08/2021 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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