Premarket Approval (PMA)

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.

• Trade Name: ESSURE SYSTEM
• Classification Name: insert, tubal occlusion
• Generic Name: device, occlusion, tubal, contraceptive
• Regulation Number: 884.5380
• Applicant: CONCEPTUS, INC.
• PMA Number: P020014
• Supplement Number: S026
• Date Received: 05/15/2009
• Decision Date: 07/16/2009
• Product Code: HHS [ Registered Establishments with HHS ]
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: location change: sterilizer
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a manufacturing site located at availmed s. A. De c. V. , tijuana, mexico.