Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- Assisted Reproduction DevicesCFR Sub-Part
- Cardiovascular Monitoring DevicesCFR Sub-Part
- Cardiovascular Prosthetic DevicesCFR Sub-Part
- Clinical Chemistry Test SystemsCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- NRZAblation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided3Product Code
- OVXWater Immersion Labor PoolNProduct Code
- PASRf/Microwave Hyperthermia System, Cancer TreatmentFProduct Code
- HHYProsthesis, Suture, Cerclage3Product Code
- LHDDevice, Fertility Diagnostic, ProceptiveUProduct Code
- LLQCap, Cervical, Contraceptive3Product Code
- LLXCatheter, Sampling, Chorionic Villus3Product Code
- LOBDilator, Cervical, Synthetic, Osmotic, Pregnancy Termination3Product Code
- LTAFluid, Hysteroscopy3Product Code
- LTYFluid, Cytological Collection3Product Code
- MCIGraft, Vascular, Hemodialysis Access, Synthetic/Biological Composite3Product Code
- MCNBarrier, Absorbable, Adhesion3Product Code
- MCPStimulator, Fetal, Acoustic3Product Code
- MGIAspirator, Ultrasonic3Product Code
- MKNCatheter, Balloon, Transcervical3Product Code
- MMAOximeter, Fetal Pulse3Product Code
- MNBDevice, Thermal Ablation, Endometrial3Product Code
- MPRStent, Bladder, FetalFProduct Code
- MPTContraception CalculatorUProduct Code
- MWMSensor, Electro-Optical (For Cervical Cancer)3Product Code
- PKFD And C TrayNProduct Code
- QLHSystem, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber LedNProduct Code
- QRZExternal Condom For Anal Intercourse Or Vaginal Intercourse2Product Code
- Submissions with No Product CodeMiscellaneous
- Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Prosthetic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
EXABLATE
- Page Type
- PMA Approval
- FDA Hosted 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