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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
PMA NumberP980049
Supplement NumberS010
Date Received09/11/2003
Decision Date10/14/2003
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the programming head of the orchestra programmer, including the addition of high-speed telemetry and other changes. The device, as modified, will be marketed under the trade name cpr3 programming head and is indicated for use with the orchestra dedicated programmer to interrogate and program ela medical pulse generators via bi-directional telemetry.