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: PRIME{TM} MODEL 6520, 6525, 6530 AND 6535
• Generic Name: Catheters, transluminal coronary angioplasty, percutaneous
• Regulation Number: 870.5100
• Applicant: Medtronic, Inc.; 8200 Coral Sea St. N.E; Ms Mvs11; Mounds View, MN 55112
• PMA Number: P870021
• Supplement Number: S003
• Date Received: 06/07/1989
• Decision Date: 09/05/1989
• Reclassified Date: 10/08/2010
• 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