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: SYNCROMED(R) INFUSION SYSTEM
• Classification Name: pump, infusion, implanted, programmable
• Generic Name: implanted infusion pump
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P860004
• Supplement Number: S020
• Date Received: 08/29/1991
• Decision Date: 10/28/1991
• Product Code: LKK [ Registered Establishments with LKK ]
• Advisory Committee: General Hospital
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - indications
• Expedited Review Granted?: No
• Combination Product: No