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
- 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
- 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
- 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
- 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
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction 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
THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
- Page Type
- PMA Approval
- Full PDF / Letter* The FDA doesn't provide PDFs for all submissions.
- Applicant
- GYNECARE, INC.
- Trade Name
- THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
- Generic Name
- Device, thermal ablation, endometrial
- Decision Date
- 12/12/1997
- Days to Decision
- 178 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval