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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.
Classification Namecondom, female, single-use
Generic Namecondom, female, single-use
515 north state st.
suite 2225
chicago, IL 60654
PMA NumberP910064
Supplement NumberS013
Date Received02/28/1997
Decision Date03/07/1997
Product Code
MBU[ Registered Establishments with MBU ]
Docket Number N
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1)a modification of the shelf life protocol to revise the film strength specification from 35 mpa to 25. 8 mpa; 2) a modification on the shelf life protocol to assess the final results of each lot on an individual basis, instead of as an average of a series; and 3) an extension of the product shelf life from 36 months to 60 months for product product manufactured at both the wisconsin pharmacal and the chartex manufacturing plants.