MetriQ Irrigation Tubing Set

FDA Premarket Approval P150005 S057

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

Modify the loctite adhesive material used in the manufacture of the metriq irrigation tubing set

DeviceMetriQ Irrigation Tubing Set
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantBoston Scientific Corp.
Date Received2020-09-28
Decision Date2020-10-09
PMAP150005
SupplementS057
Product CodeOAD 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134

Supplemental Filings

Supplement NumberDateSupplement Type
P150005Original Filing
S057 2020-09-28 Real-time Process
S056 2020-05-21 30-day Notice
S055 2020-05-15 30-day Notice
S054 2020-04-30 Normal 180 Day Track No User Fee
S053 2020-03-12 Normal 180 Day Track No User Fee
S052 2020-01-22 30-day Notice
S051 2019-11-22 Real-time Process
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

NIH GUDID Devices

Device IDPMASupp
08714729862208 P150005 000
08714729862208 P150005 000
08714729862208 P150005 000
08714729862208 P150005 000
08714729862208 P150005 000
08714729862208 P150005 000
08714729862208 P150005 000
08714729862208 P150005 000
08714729938361 P150005 017
08714729938378 P150005 017
08714729938385 P150005 017

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