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: ANGIOPLASTY (PTCA) DILATATION CATHETERS
• Generic Name: Catheters, transluminal coronary angioplasty, percutaneous
• Regulation Number: 870.5100
• Applicant: Cordis Corp.; P.O. Box 025700; Miami, FL 33102
• PMA Number: P890032
• Supplement Number: S001
• Date Received: 03/12/1990
• Decision Date: 04/30/1990
• Withdrawal Date: 09/02/2008
• Product Code: LOX
• Advisory Committee: Cardiovascular
• 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