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: SYNCHROMED IMPLANTABLE PUMP SYSTEM
• Classification Name: pump, infusion, implanted, programmable
• Generic Name: implantable infusion pumps
• Applicant: MEDTRONIC NEUROMODULATION
• PMA Number: P860004
• Supplement Number: S079
• Date Received: 12/02/2005
• Decision Date: 03/22/2006
• Product Code: LKK [ Registered Establishments with LKK ]
• Advisory Committee: General Hospital
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Approval for revised labeling for the manuals for the device.