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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Namecardiovascular permanent pacemaker electrode
ApplicantPACESETTER, INC.
PMA NumberP960013
Date Received05/10/1996
Decision Date06/20/1997
Product Code
NVN[ Registered Establishments with NVN ]
Docket Number 98M-0450
Notice Date 07/16/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the tendril(r) dx models 388t/k endocardial, steroid eluting, screw-in pacing leads and ventritex assure(tm) afs models 7010t/k endocardial, sterioid eluting screw-in pacing leads. These devices are indicated for use in combination iwth a compatible pulse generator to provide permanent pacing and sensing in either the atrium or ventricle.
Supplements: S001 S002 S004 S005 S006 S007 
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S064 S065 S066 S067 S068 S069 
S070 S071 S072 S074 
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