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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 25 Results
productcode LPB PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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RF Conductr, RF Enhancr II, RF Marinr, RF Unipolar... MEDTRONIC Inc. P930029 S071 06/01/2022
Blazer II Cardiac Ablation System and Cable Boston Scientific Corp. P920047 S129 11/15/2022
INTELLANAV™ ST Ablation Catheter, BLAZER™ II Tempe... Boston Scientific Corp. P920047 S128 09/21/2022
Blazer II Catheter, Blazer II HTD Catheter, Blazer... Boston Scientific Corp. P920047 S127 02/25/2022
IntellaNav™ ST Ablation Catheter, Blazer™ II Tempe... Boston Scientific Corp. P920047 S126 02/22/2022
FlexAbility™ Ablation Catheter, Sensor Enabled™ Abbott Medical P110016 S080 12/14/2022
ThermoCool SmartTouch Catheters, NaviStar ThermoCo... BIOSENSE WEBSTER, INC. P040036 S090 09/30/2022
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST) BIOSENSE WEBSTER, INC. P040036 S089 09/09/2022
ThermoCool SmartTouch SF BIOSENSE WEBSTER, INC. P040036 S087 02/01/2022
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH BIOSENSE WEBSTER, INC. P040036 S084 03/08/2022
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