Blazer Open Irrigated Temperature Ablation Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Premarket Approval P150005 S050

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.

Pre-market Approval Supplement Details

To reduce the ethylene oxide gas concentration and qualify additional process challenge devices used in the bsc2000-2 sterilization cycle

DeviceBlazer Open Irrigated Temperature Ablation Catheter
Classification NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantBoston Scientific Corp.
Date Received2019-10-10
Decision Date2019-11-07
PMAP150005
SupplementS050
Product CodeOAD
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134

Supplemental Filings

Supplement NumberDateSupplement Type
P150005Original Filing
S050 2019-10-10 30-day Notice
S049
S048 2019-09-30 30-day Notice
S047 2019-06-14 Real-time Process
S046 2019-05-08 30-day Notice
S045
S044 2019-04-08 30-day Notice
S043
S042 2019-03-20 30-day Notice
S041 2018-10-25 135 Review Track For 30-day Notice
S040 2018-08-24 30-day Notice
S039 2018-06-21 Normal 180 Day Track
S038 2018-06-13 30-day Notice
S037 2018-04-27 Normal 180 Day Track No User Fee
S036 2018-04-06 135 Review Track For 30-day Notice
S035 2018-02-02 Normal 180 Day Track
S034 2018-01-17 30-day Notice
S033 2017-12-15 Real-time Process
S032 2017-10-30 30-day Notice
S031 2017-10-26 30-day Notice
S030 2017-10-02 30-day Notice
S029 2017-09-15 30-day Notice
S028 2017-09-14 30-day Notice
S027 2017-08-30 30-day Notice
S026 2017-08-25 30-day Notice
S025 2017-08-14 30-day Notice
S024 2017-08-04 30-day Notice
S023 2017-07-18 30-day Notice
S022 2017-06-26 30-day Notice
S021 2017-05-18 30-day Notice
S020 2017-04-27 Real-time Process
S019 2017-04-13 30-day Notice
S018 2017-03-17 30-day Notice
S017 2017-03-16 Normal 180 Day Track
S016 2017-03-06 30-day Notice
S015 2017-03-03 Real-time Process
S014 2017-02-22 Panel Track
S013 2016-11-17 Normal 180 Day Track No User Fee
S012 2016-11-09 30-day Notice
S011 2016-11-07 135 Review Track For 30-day Notice
S010 2016-07-21 30-day Notice
S009 2016-07-21 30-day Notice
S008 2016-05-02 Normal 180 Day Track
S007 2016-04-15 135 Review Track For 30-day Notice
S006 2016-04-11 Normal 180 Day Track No User Fee
S005 2016-04-11 Normal 180 Day Track
S004 2016-03-21 135 Review Track For 30-day Notice
S003
S002 2016-03-01 30-day Notice
S001 2016-03-01 Normal 180 Day Track No User Fee

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