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: SPRINTER OVER-THE-WIRE BALLOON DILATATION CATHETER
• Classification Name: catheters, transluminal coronary angioplasty, percutaneous
• Generic Name: ptca catheter
• Regulation Number: 870.5100
• Applicant: MEDTRONIC IRELAND
• PMA Number: P790017
• Supplement Number: S087
• Date Received: 07/23/2007
• Decision Date: 08/22/2007
• Product Code: LOX [ Registered Establishments with LOX ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Adding the option to sterilize the subject device twice.