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: SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
• Generic Name: Catheters, transluminal coronary angioplasty, percutaneous
• Regulation Number: 870.5100
• Applicant: Advanced Cardiovascular Systems, Inc.; 26531 Ynez Rd.; Temecula, CA 92591
• PMA Number: P810046
• Supplement Number: S045
• Date Received: 04/01/1988
• Decision Date: 09/23/1988
• Reclassified Date: 10/08/2010
• Product Code: LOX
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No