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 | BLAZER™ Solid-Tip Ablation Catheter Cable 10’, BLAZER™ Solid-Tip Ablation Catheter Cable 3’, INTELLATIP MIFI™ XP Cable, |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P020025 |
Supplement Number | S139 |
Date Received | 06/21/2023 |
Decision Date | 04/05/2024 |
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 manufacturing site transfer for the Rx Sterile Catheter Cables and Non-Sterile Recording System Electrogram (EGM) Cable to Amphenol Alden Products Company in Hermosillo, Mexico; Amphenol Alden Products Company in Shenzhen, China; and Carrio Cabling Corporation in Colorado Springs, Colorado |
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