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: LAMICEL(TM)
• Generic Name: dilator, cervical, synthetic, osmotic, pregnancy termination
• Applicant: Medtronic Xomed, Inc.; 6743 SOUTHPOINT DR. N.; JACKSONVILLE, FL 32216
• PMA Number: P820075
• Supplement Number: S002
• Date Received: 12/03/1984
• Decision Date: 08/22/1986
• Withdrawal Date: 01/31/2007
• Product Code: LOB
• Advisory Committee: Obstetrics/Gynecology
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls