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- 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
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- MMAOximeter, Fetal Pulse3Product Code
- MNBDevice, Thermal Ablation, Endometrial3Product Code
- P230002Minitouch 3.8 Era System (Minitouch System)APPRPMA Approval
- P180032Cerene® Cryotherapy DeviceAPPRPMA Approval
- P160047AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KITAPPRPMA Approval
- P140013MINERVA ENDOMETRIAL ABLATION SYSTEMAPPRPMA Approval
- P020031MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEMAPWDPMA Approval
- P010013NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEMAPPRPMA Approval
- P000040HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEMAPPRPMA Approval
- P000032HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEMAPPRPMA Approval
- P970021THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEMAPWDPMA Approval
- MPRStent, Bladder, FetalFProduct Code
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- 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
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
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- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
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- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
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- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
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Cerene® Cryotherapy Device
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Channel Medsystems, Inc.
- Trade Name
- Cerene® Cryotherapy Device
- Generic Name
- Device, thermal ablation, endometrial
- Decision Date
- 3/28/2019
- Days to Decision
- 227 days
- Decision Code
- APPR
- FDA Decision
- Approval