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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170
Generic NamePulse-generator, pacemaker, external
ApplicantPACE MEDICAL
391 TOTTEN POND RD.
WALTHAM, MA 02451
PMA NumberP920032
Supplement NumberS007
Date Received04/24/2001
Decision Date10/26/2001
Product Codes DTE JOQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODEL 4170 BEDSIDE SINGLE CHAMBER, EXTERNAL PULSE GENERATOR. THE MODEL 4170 IS INDICATED FOR "ANY CLINICAL SITUATION IN WHICH THE USE OF TEMPORARY PACEMAKER ON A PATIENT PROVIDES THERAPEUTIC OR DIAGNOSTIC VALUE, OR SERVES A PROPHYLACTIC PURPOSE. SPECIFICALLY, INDICATIONS FOR TEMPORARY PACEMAKERS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: INTERMITTENT OR COMPLETE HEART BLOCK ASSOCIATED WITH ASYSTOLE OR BRADYCARDIA, SYMPTOMATIC SINUS BRADYCARDIA, SURGICALLY-INDUCED HEART BLOCK AND HEART BLOCK ACCOMPANYING AN ACUTE MYOCARDIAL INFARCTION."
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