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

FDA Premarket Approval P040014 S047

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

• Device: Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)
• Generic Name: Cardiac Ablation Percutaneous Catheter
• Applicant: IRVINE BIOMEDICAL, INC.2375 Morse Ave.irvine, CA 92614 PMA NumberP040014 Supplement NumberS047 Date Received10/28/2022 Decision Date12/16/2022 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 Received: 2022-10-28
• Decision Date: 2022-12-16
• PMA: P040014
• Supplement: S047
• Product Code: LPB
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: IRVINE BIOMEDICAL, INC.; 2375 Morse Ave.; irvine, CA 92614 PMA NumberP040014 Supplement NumberS047 Date Received10/28/2022 Decision Date12/16/2022 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 Sterigenics Utah As An Alternate EO Sterilization Vendor For Irvine EP Cables.

Supplemental Filings

Supplement Number	Date	Supplement Type
P040014		Original 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 ID	PMA	Supp
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