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: GEMINI(R) THETA MODEL 415A CARDIAC PACER
• Classification Name: implantable pulse generator, pacemaker (non-crt)
• Generic Name: dual chamber, implantable pulse generator
• Applicant: TELECTRONICS PACING SYSTEMS, INC.
• PMA Number: P830007
• Supplement Number: S032
• Date Received: 04/19/1990
• Decision Date: 05/09/1990
• Product Code: LWP [ Registered Establishments with LWP ]
• Advisory Committee: Anesthesiology
• Supplement Type: normal 180 day track
• Supplement Reason: location change: sterilizer
• Expedited Review Granted?: No
• Combination Product: No