IntellaNav MiFi Open-Irrigated (OI) and IntellaTip MiFi OI ablation catheters

FDA Premarket Approval P150005 S056

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 add an alternate supplier (rms) for the proximal insert component used in manufacturing of the ablation catheters

DeviceIntellaNav MiFi Open-Irrigated (OI) and IntellaTip MiFi OI ablation catheters
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantBoston Scientific Corp.
Date Received2020-05-21
Decision Date2020-06-04
PMAP150005
SupplementS056
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
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
08714729938385 P150005 017
08714729938378 P150005 017
08714729938361 P150005 017

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