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 INFUSION SYSTEM
• Classification Name: pump, infusion, implanted, programmable
• Generic Name: implantable infusion pumps
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P860004
• Supplement Number: S047
• Date Received: 07/05/2001
• Decision Date: 08/01/2001
• Product Code: LKK [ Registered Establishments with LKK ]
• Advisory Committee: General Hospital
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for additional labeling for pump replacement procedures.