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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.
 
Trade NameMODEL 6960 SWITCHABLE ECG PATIENT CABLE
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameecg cable
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS026
Date Received12/21/1998
Decision Date01/20/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approva for a switchable ecg cable that allows the clinician to display and record ecg signals from seven different vectors (leads) without moving the ecg electrodes that are attached to the patient. The device, as modified, will be marketed under the trade name model 6960 switchable ecg cable and is indicated for use as an accessory to the models 2950 and 2901 programmer/recorder/monitors (prms).
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