Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
• Classification Name: catheters, transluminal coronary angioplasty, percutaneous
• Generic Name: percutaneous transluminal balloon
• Regulation Number: 870.5100
• Applicant: BOSTON SCIENTIFIC CORP.
• PMA Number: P880065
• Date Received: 08/19/1988
• Decision Date: 09/19/1990
• Withdrawal Date: 09/20/2007
• Product Code: LOX [ Registered Establishments with LOX ]
• Docket Number: 90M-0319
• Notice Date: 10/23/1990
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S003 S004 S005 S006 ; S007 S009