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.
| 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 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 Received | 2022-10-19 |
| Decision Date | 2022-11-15 |
| PMA | P040014 |
| Supplement | S046 |
| 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 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 |
| 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 |
| 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 |