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 2000 SYSTEM |
Generic Name | Ablation system, high intensity focused ultrasound (HIFU), MR-guided |
Applicant | INSIGHTEC, LTD 4851 LBJ FRWY, STE 400 DALLAS, TX 75244 |
PMA Number | P040003 |
Supplement Number | S018 |
Date Received | 05/10/2016 |
Decision Date | 08/26/2016 |
Product Code |
NRZ |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for change to the ExAblate system to comply with the European directive 2002/95/EC and 2011/65/EU in relation to Restriction of Hazardous Substance (RoHS). |
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