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: ABBOTT IMX PSA
• Generic Name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• Regulation Number: 866.6010
• Applicant: Abbott Laboratories; 100 Abbott Park Rd.; Abbott Park, IL 60064
• PMA Number: P910007
• Supplement Number: S003
• Date Received: 08/29/1994
• Decision Date: 10/17/1994
• Product Code: LTJ
• Advisory Committee: Immunology
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No