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: DRILAC{TM} CUBES
• Generic Name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
• Applicant: Osmed, Inc.; 325 Lake Ave. S. - Suite; #608; Duluth, MN 55802
• PMA Number: P800012
• Supplement Number: S004
• Date Received: 08/14/1986
• Decision Date: 12/22/1986
• Withdrawal Date: 04/25/2007
• Product Code: LPG
• Advisory Committee: Dental
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No