Premarket Approval (PMA)

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.

• Device: ESSURE SYSTEM
• Generic Name: Transcervical contraceptive tubal occlusion device
• Regulation Number: 884.5380
• Applicant: Bayer Pharma AG; Mollerstrabe 178; Berlin 13353
• PMA Number: P020014
• Supplement Number: S044
• Date Received: 09/01/2015
• Decision Date: 05/12/2016
• Product Code: HHS
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of changes to the post-approval study protocol.