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: LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT
• Generic Name: Catheters, transluminal coronary angioplasty, percutaneous
• Regulation Number: 870.5100
• Applicant: Leocor, Inc.; 1301 Regents Pk. Dr.; Houston, TX 77058
• PMA Number: P890001
• Supplement Number: S010
• Date Received: 10/07/1993
• Decision Date: 08/04/1994
• Product Code: LOX
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No