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23
0002
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18
0032
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16
0047
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14
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02
0031
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01
0013
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APPR
PMA Approval
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00
0040
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PMA Approval
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00
0032
HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
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97
0021
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Last synced on 20 December 2024 at 11:05 pm
OB
/
OB-misc
/
MNB
/
P000032
View Source
HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
CooperSurgical, Inc.
Trade Name
HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
Generic Name
Device, thermal ablation, endometrial
Decision Date
4/20/2001
Days to Decision
267 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
OVX
Water Immersion Labor Pool
PAS
Rf/Microwave Hyperthermia System, Cancer Treatment
HHY
Prosthesis, Suture, Cerclage
LHD
Device, Fertility Diagnostic, Proceptive
LLQ
Cap, Cervical, Contraceptive
LLX
Catheter, Sampling, Chorionic Villus
LOB
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
LTA
Fluid, Hysteroscopy
LTY
Fluid, Cytological Collection
MCI
Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
MCN
Barrier, Absorbable, Adhesion
MCP
Stimulator, Fetal, Acoustic
MGI
Aspirator, Ultrasonic
MKN
Catheter, Balloon, Transcervical
MMA
Oximeter, Fetal Pulse
MNB
Device, Thermal Ablation, Endometrial
P
23
0002
Minitouch 3.8 Era System (Minitouch System)
P
18
0032
Cerene® Cryotherapy Device
P
16
0047
AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT
P
14
0013
MINERVA ENDOMETRIAL ABLATION SYSTEM
P
02
0031
MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
P
01
0013
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
P
00
0040
HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
P
00
0032
HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
P
97
0021
THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
MPR
Stent, Bladder, Fetal
MPT
Contraception Calculator
MWM
Sensor, Electro-Optical (For Cervical Cancer)
PKF
D And C Tray
QLH
System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led
QRZ
External Condom For Anal Intercourse Or Vaginal Intercourse
Submissions with No Product Code
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
OB-misc
/
MNB
/
P000032
View Source
HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
CooperSurgical, Inc.
Trade Name
HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
Generic Name
Device, thermal ablation, endometrial
Decision Date
4/20/2001
Days to Decision
267 days
Decision Code
APPR
FDA Decision
Approval