EXABLATE

Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided

FDA Premarket Approval P110039 S006

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.

Pre-market Approval Supplement Details

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).

DeviceEXABLATE
Classification NameAblation System, High Intensity Focused Ultrasound (hifu), Mr-guided
Generic NameAblation System, High Intensity Focused Ultrasound (hifu), Mr-guided
ApplicantInSightec
Date Received2016-05-10
Decision Date2016-08-26
PMAP110039
SupplementS006
Product CodeNRZ
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address InSightec 5 Nahum Heth Street tirat-carmel 39120

Supplemental Filings

Supplement NumberDateSupplement Type
P110039Original Filing
S010 2018-04-26 Real-time Process
S009
S008 2017-09-22 Normal 180 Day Track
S007
S006 2016-05-10 Real-time Process
S005 2016-04-04 Real-time Process
S004 2013-09-23 Real-time Process
S003 2013-06-28 Normal 180 Day Track No User Fee
S002 2012-11-06 Normal 180 Day Track No User Fee
S001 2012-11-06 Normal 180 Day Track No User Fee

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