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 | Exablate 4000 System |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S011 |
Date Received | 03/26/2019 |
Decision Date | 04/25/2019 |
Product Code |
POH |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Introduction of a US based warehouse and distribution facility for the purpose of receipt, handling, storage, shipping, and distributing of ExablateTreatment Kits and for storing replacement parts. |
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