Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)

FDA Premarket Approval P040014 S046

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

DeviceTherapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantIRVINE BIOMEDICAL, INC.2375 Morse Ave.irvine, CA 92614 PMA NumberP040014 Supplement NumberS046 Date Received10/19/2022 Decision Date11/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-19
Decision Date2022-11-15
PMAP040014
SupplementS046
Product CodeLPB 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressIRVINE BIOMEDICAL, INC.
2375 Morse Ave.
irvine, CA 92614 PMA NumberP040014 Supplement NumberS046 Date Received10/19/2022 Decision Date11/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For A Manufacturing Site Located At CENTERPIECE S. DE R.L. DE C.V., Bulevar La Encantada Industrial, Parque Industrial El Florido, Seccion La Encantada #11530, Tijuana, Baja California, Mexico, 22250 For Ethylene Oxide Sterilization Activities

Supplemental Filings

Supplement NumberDateSupplement Type
P040014Original Filing
S047 2022-10-28 Normal 180 Day Track No User Fee
S046 2022-10-19 Normal 180 Day Track No User Fee
S045 2021-09-14 30-day Notice
S044 2021-04-13 30-day Notice
S043 2021-02-25 30-day Notice
S042 2021-01-13 Real-time Process
S041 2020-09-18 30-day Notice
S040
S039 2020-02-20 Real-time Process
S038 2020-02-04 30-day Notice
S037 2019-07-29 30-day Notice
S036 2019-03-15 30-day Notice
S035 2018-12-12 Special (immediate Track)
S034 2018-02-05 30-day Notice
S033
S032 2017-05-04 30-day Notice
S031 2016-08-12 30-day Notice
S030 2016-05-27 30-day Notice
S029 2016-02-19 30-day Notice
S028 2015-11-20 Real-time Process
S027 2015-09-23 30-day Notice
S026 2015-08-21 Normal 180 Day Track No User Fee
S025 2015-04-20 30-day Notice
S024 2014-11-07 Real-time Process
S023 2014-04-30 Normal 180 Day Track No User Fee
S022 2014-03-03 Real-time Process
S021 2013-11-27 Normal 180 Day Track
S020 2013-08-30 30-day Notice
S019 2011-11-29 135 Review Track For 30-day Notice
S018 2011-10-14 30-day Notice
S017 2011-05-09 30-day Notice
S016 2011-01-18 30-day Notice
S015 2010-11-16 Real-time Process
S014
S013 2010-02-22 30-day Notice
S012 2009-12-14 30-day Notice
S011 2009-07-30 30-day Notice
S010 2009-05-04 30-day Notice
S009 2008-11-10 30-day Notice
S008 2008-09-04 Normal 180 Day Track
S007 2008-05-14 30-day Notice
S006 2007-02-12 Real-time Process
S005 2006-12-18 135 Review Track For 30-day Notice
S004 2006-09-05 Normal 180 Day Track
S003 2006-06-12 Normal 180 Day Track
S002 2005-11-09 30-day Notice
S001 2005-04-01 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05414734309110 P040014 000
05414734306928 P040014 000
05414734306935 P040014 000
05414734306942 P040014 000
05414734306959 P040014 000
05414734306911 P040014 000
05414734308755 P040014 000
05414734308830 P040014 000
05414734308854 P040014 001
05414734308847 P040014 001
05414734308335 P040014 003
05414734308359 P040014 003
05414734308342 P040014 003
05414734308977 P040014 004
05414734308403 P040014 004
05414734308397 P040014 004
05414734308380 P040014 004

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