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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHER OPTION UTERINE CRYOBLATION THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
ApplicantAMERICAN MEDICAL SYSTEMS GYNECOLOGY,INC
PMA NumberP000032
Supplement NumberS001
Date Received08/09/2001
Decision Date09/07/2001
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the her option(tm) uterine cryoblation therapy(tm) system labeling.
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