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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 168 Results
Applicant: BIOSENSE WEBSTER, INC Product Code: LPB Decision Date to 06/25/2017
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thermocool smart touch bi-directional and electrophysiology BIOSENSE WEBSTER, INC. P040036 S057 09/21/2016
thermocool smarttouch sf uni-directional navigation catheter... BIOSENSE WEBSTER, INC. P030031 S072 08/11/2016
smartablate system: smartablate rf generator and remote cont... BIOSENSE WEBSTER, INC. P990071 S033 08/04/2016
thermocool smarttouch bi-directional navigation catheter BIOSENSE WEBSTER, INC. P040036 S056 07/18/2016
thermocool smart touch uni-directional navigation catheter BIOSENSE WEBSTER, INC. P040036 S054 04/25/2016
celsius rmt thermoccol cat, celsius thermoccol cath navistar... BIOSENSE WEBSTER, INC. P030031 S059 12/17/2015
ez steer thermocool cath, ez steer thermocool nav cath navis... BIOSENSE WEBSTER, INC. P040036 S044 12/17/2015
biosense webster cables, ez steer nav catheter, navistar cat... BIOSENSE WEBSTER, INC. P990025 S040 12/17/2015
biosense webster cables BIOSENSE WEBSTER, INC. P990071 S028 12/17/2015
celsius thermocool, thermocool sf, navistar thermocool, ther... BIOSENSE WEBSTER, INC. P030031 S071 11/05/2015