Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: USCI GRUNTZIG DILACA CATHETER
• Classification Name: catheters, transluminal coronary angioplasty, percutaneous
• Generic Name: cv balloon dilation catheter
• Regulation Number: 870.5100
• Applicant: C.R. BARD, INC.
• PMA Number: P790017
• Supplement Number: S007
• Date Received: 07/22/1983
• Decision Date: 12/14/1983
• Product Code: LOX [ Registered Establishments with LOX ]
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No