Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: LEA'S SHIELD BARRIER CONTRACEPTIVE
• Generic Name: Cap, cervical, contraceptive
• Applicant: YAMA, INC.; P.O. BOX 884; MILLBURN, NJ 07041
• PMA Number: P010043
• Date Received: 08/13/2001
• Decision Date: 03/14/2002
• Product Code: 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