• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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 NumberS007
Date Received10/04/1993
Decision Date07/31/1995
Product Code
MBU[ Registered Establishments with MBU ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change to the professional monograph & patient device labeling to include information on, or instructions for, the concomitant use of a spermicide containing nonoxynol-9 w/reality female condom.