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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 2901 PROGRAMMER
Classification Nameprogrammer, pacemaker
Generic Namepulse generator, programmer
Regulation Number870.3700
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS014
Date Received03/25/1996
Decision Date11/07/1996
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a 1)new programming system, the model 2901 prm programming system with the commercially available ventak prxii/prxiii, mini pulse genertors and accessories, and 2) a new manufacturing contract facility, emd associates, inc. (emd), 4065 theurer blvd. , winona, mn 55987.
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