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: MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525
• Classification Name: permanent pacemaker electrode
• Generic Name: model 5525 transvenous atrail & model 5025 ventr
• Regulation Number: 870.3680
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P850089
• Supplement Number: S003
• Date Received: 09/25/1986
• Decision Date: 10/07/1986
• Product Code: DTB [ Registered Establishments with DTB ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No