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 | Celsius FLTRR, EZ Steer Nav DS Catheter |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-02 |
| Decision Date | 2022-09-30 |
| PMA | P010068 |
| Supplement | S070 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOSENSE WEBSTER, INC. 31 Technology Drive suite 200 irvine, CA 92618 PMA NumberP010068 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Add An Additional Chamber For The Sterilization Of Catheters And Cables At The Isomedix Operation, Inc. (Steris Grand Prairie) Facility In Grand Prairie, Texas |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010068 | Original Filing | |
| S070 | 2022-09-02 | 30-day Notice |
| S069 | 2022-06-10 | Normal 180 Day Track |
| S068 | 2021-08-23 | Normal 180 Day Track No User Fee |
| S067 | ||
| S066 | 2021-06-11 | 30-day Notice |
| S065 | ||
| S064 | 2021-04-12 | 30-day Notice |
| S063 | 2021-03-31 | 30-day Notice |
| S062 | 2021-03-02 | Special (immediate Track) |
| S061 | 2021-01-28 | 30-day Notice |
| S060 | 2020-09-15 | 30-day Notice |
| S059 | 2020-03-13 | 30-day Notice |
| S058 | 2020-01-16 | 30-day Notice |
| S057 | 2018-07-02 | 30-day Notice |
| S056 | 2017-10-03 | 30-day Notice |
| S055 | 2017-09-11 | 30-day Notice |
| S054 | 2017-06-30 | 30-day Notice |
| S053 | 2017-06-02 | 135 Review Track For 30-day Notice |
| S052 | 2016-08-26 | 30-day Notice |
| S051 | 2016-06-13 | Normal 180 Day Track |
| S050 | 2016-03-31 | 30-day Notice |
| S049 | 2015-10-09 | 30-day Notice |
| S048 | 2015-07-17 | 30-day Notice |
| S047 | 2015-05-06 | 30-day Notice |
| S046 | 2015-02-20 | 30-day Notice |
| S045 | 2015-02-20 | 30-day Notice |
| S044 | 2014-11-14 | 30-day Notice |
| S043 | 2014-09-29 | Real-time Process |
| S042 | 2014-09-22 | 30-day Notice |
| S041 | 2014-08-14 | 30-day Notice |
| S040 | 2014-07-02 | Normal 180 Day Track No User Fee |
| S039 | 2014-04-03 | 135 Review Track For 30-day Notice |
| S038 | 2013-12-27 | 30-day Notice |
| S037 | 2013-10-18 | 30-day Notice |
| S036 | 2013-11-01 | Real-time Process |
| S035 | 2013-08-09 | 30-day Notice |
| S034 | 2013-04-26 | 30-day Notice |
| S033 | 2013-03-27 | 30-day Notice |
| S032 | 2013-03-21 | 135 Review Track For 30-day Notice |
| S031 | 2012-11-07 | Normal 180 Day Track |
| S030 | 2012-09-25 | 30-day Notice |
| S029 | 2012-06-19 | 30-day Notice |
| S028 | 2012-06-19 | Normal 180 Day Track |
| S027 | 2012-04-16 | Normal 180 Day Track |
| S026 | 2012-03-02 | 30-day Notice |
| S025 | 2011-08-29 | 30-day Notice |
| S024 | 2011-03-01 | 30-day Notice |
| S023 | 2011-03-01 | 135 Review Track For 30-day Notice |
| S022 | 2011-01-31 | 30-day Notice |
| S021 | 2010-10-27 | Normal 180 Day Track No User Fee |
| S020 | 2010-03-02 | Normal 180 Day Track No User Fee |
| S019 | 2010-02-05 | 30-day Notice |
| S018 | 2009-10-09 | Real-time Process |
| S017 | 2009-09-28 | Real-time Process |
| S016 | ||
| S015 | ||
| S014 | 2009-04-15 | 30-day Notice |
| S013 | 2008-10-09 | Special (immediate Track) |
| S012 | 2007-12-14 | Normal 180 Day Track No User Fee |
| S011 | 2007-10-04 | 30-day Notice |
| S010 | 2007-07-31 | 30-day Notice |
| S009 | 2006-01-31 | Normal 180 Day Track |
| S008 | 2006-01-26 | 30-day Notice |
| S007 | 2005-09-22 | Normal 180 Day Track No User Fee |
| S006 | 2005-09-06 | Normal 180 Day Track |
| S005 | 2004-11-03 | Normal 180 Day Track No User Fee |
| S004 | 2004-07-28 | Real-time Process |
| S003 | 2004-03-11 | Normal 180 Day Track No User Fee |
| S002 | 2003-11-03 | Real-time Process |
| S001 | 2003-01-02 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 10846835003680 | P010068 | 000 |
| 10846835000399 | P010068 | 000 |
| 10846835000580 | P010068 | 000 |
| 10846835000603 | P010068 | 000 |
| 10846835000627 | P010068 | 000 |
| 10846835003697 | P010068 | 000 |
| 10846835006094 | P010068 | 000 |
| 10846835006124 | P010068 | 000 |
| 10846835006148 | P010068 | 000 |
| 10846835006193 | P010068 | 000 |
| 10846835008524 | P010068 | 000 |
| 10846835003666 | P010068 | 000 |
| 10846835003406 | P010068 | 000 |
| 10846835008548 | P010068 | 000 |
| 10846835000191 | P010068 | 000 |
| 10846835000184 | P010068 | 000 |
| 10846835002980 | P010068 | 006 |
| 10846835003000 | P010068 | 006 |
| 10846835003024 | P010068 | 006 |
| 10846835003048 | P010068 | 006 |
| 10846835003062 | P010068 | 006 |
| 10846835013078 | P010068 | 031 |
| 10846835013061 | P010068 | 031 |
| 10846835018080 | P010068 | 067 |