• 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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecap, cervical, contraceptive
Generic Namecap, cervical, contraceptive
p.o. box 884
millburn, NJ 07041
PMA NumberP010043
Date Received08/13/2001
Decision Date03/14/2002
Product Code
LLQ[ Registered Establishments with LLQ ]
Docket Number 02M-0471
Notice Date 10/30/2002
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the lea's shield barrier contraceptive. The device is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001