Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceREALITY FEMALE CONDOM
Generic NameSingle-use internal condom
Regulation Number884.5340
ApplicantThe Female Health Co.
515 N. State St.
Suite 2225
Chicago, IL 60654
PMA NumberP910064
Supplement NumberS001
Date Received05/26/1993
Decision Date07/24/1995
Withdrawal Date09/01/2010
Product Code MBU 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ACCELERATED & REAL-TIME AGING STUDIES TO ESTABLISH A NEW SHELF LIFE FOR THE REALITY FEMALE CONDOM
-
-