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 OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P150005 |
Supplement Number | S041 |
Date Received | 10/25/2018 |
Decision Date | 01/09/2019 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of manufacturing changes, specifically, the addition of BSC Heredia as an alternate supplier for the Steering Control Wire Subassembly. |
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