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 SYNCROMED INFUSION SYS. MODEL 8550 REFIL
• Classification Name: pump, infusion, implanted, programmable
• Generic Name: implanted infusion pump
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P860004
• Supplement Number: S023
• Date Received: 10/04/1991
• Decision Date: 03/24/1992
• Product Code: LKK [ Registered Establishments with LKK ]
• Advisory Committee: General Hospital
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications - other
• Expedited Review Granted?: No
• Combination Product: No