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: AMIKACIN ELUTION DISK FOR AUTOBAC
• Generic Name: DISCS, ELUTION
• Regulation Number: 866.1620
• Applicant: Organon Teknika Corp.; 800 Capitola Dr.; Durham, NC 27713
• PMA Number: N50485
• Supplement Number: S007
• Date Received: 09/13/1983
• Decision Date: 03/15/1984
• Product Code: LTX
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No