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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 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S053 S054 S055 S056 
S057 S058 S059 S060 S062 S063 S064 S065 S066 
S067 S068 S069 S070 S071 S072 S074 S075 S076 
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