Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• 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 STREET NE; MS MV S11; MOUNDS VIEW, MN 55112
• PMA Number: P870021
• Date Received: 05/05/1987
• Decision Date: 02/29/1988
• Reclassified Date: 10/08/2010
• Product Code: LOX
• Docket Number: 88M-0106
• Notice Date: 05/11/1988
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S003 S004