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: MODEL 1256D META MV CARDIAC PULSE GENERATOR
• Classification Name: implantable pacemaker pulse-generator
• Generic Name: cardiac pacing system
• Regulation Number: 870.3610
• Applicant: PACESETTER, INC.
• PMA Number: P900070
• Supplement Number: S018
• Date Received: 04/08/1997
• Decision Date: 04/29/1997
• Product Code: DXY [ Registered Establishments with DXY ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: location change: manufacturer
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for alternate manufacturing site located at sylmar, ca.