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: INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400
• Classification Name: pump, infusion, implanted, programmable
• Generic Name: implanted infusion pump
• Applicant: INFUSAID CORP.
• PMA Number: P800036
• Supplement Number: S030
• Date Received: 12/29/1993
• Decision Date: 08/14/1995
• 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: No

Approval Order Statement 
Approval for labeling change.