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NRZ
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
3
Product Code
P
11
0039
EXABLATE
APPR
PMA Approval
Show All 2 Submissions
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Last synced on 3 April 2026 at 11:13 pm
OB
/
OB-misc
/
NRZ
/
P110039
View Source
EXABLATE
Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
InSightec
Trade Name
EXABLATE
Generic Name
Ablation system, high intensity focused ultrasound (HIFU), MR-guided
Decision Date
10/18/2012
Days to Decision
318 days
Decision Code
APPR
FDA Decision
Approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
NRZ
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
P
11
0039
EXABLATE
Show All 2 Submissions
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
OB-misc
/
NRZ
/
P110039
View Source
EXABLATE
Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
InSightec
Trade Name
EXABLATE
Generic Name
Ablation system, high intensity focused ultrasound (HIFU), MR-guided
Decision Date
10/18/2012
Days to Decision
318 days
Decision Code
APPR
FDA Decision
Approval