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 | SmartAblate Irrigation Tubing Set and nGEN Pump |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS054 Date Received05/18/2022 Decision Date06/08/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-18 |
| Decision Date | 2022-06-08 |
| PMA | P990071 |
| Supplement | S054 |
| Product Code | LPB |
| 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 NumberP990071 Supplement NumberS054 Date Received05/18/2022 Decision Date06/08/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Change In The Location For Inspection Of The SmartAblate Irrigation Tubing Set And NGEN Pump From The Irwindale, CA Site To The Irvine, CA Site |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990071 | Original Filing | |
| S056 | 2022-09-02 | 30-day Notice |
| S055 | ||
| S054 | 2022-05-18 | 30-day Notice |
| S053 | 2022-02-16 | 30-day Notice |
| S052 | 2021-08-23 | Normal 180 Day Track No User Fee |
| S051 | ||
| S050 | 2021-06-11 | 30-day Notice |
| S049 | 2021-04-12 | 30-day Notice |
| S048 | 2021-03-31 | 30-day Notice |
| S047 | ||
| S046 | ||
| S045 | 2020-09-08 | 30-day Notice |
| S044 | 2020-04-20 | Normal 180 Day Track |
| S043 | 2020-03-13 | 30-day Notice |
| S042 | 2019-01-03 | Real-time Process |
| S041 | 2018-07-02 | 30-day Notice |
| S040 | 2018-06-20 | Normal 180 Day Track No User Fee |
| S039 | 2018-05-21 | Special (immediate Track) |
| S038 | 2017-10-03 | 30-day Notice |
| S037 | 2017-09-11 | Normal 180 Day Track |
| S036 | 2017-06-02 | Real-time Process |
| S035 | 2017-05-23 | Special (immediate Track) |
| S034 | 2016-06-13 | Normal 180 Day Track |
| S033 | 2016-05-09 | Normal 180 Day Track |
| S032 | 2015-08-17 | Special (immediate Track) |
| S031 | 2015-05-18 | 30-day Notice |
| S030 | 2014-11-10 | 30-day Notice |
| S029 | 2014-09-10 | Real-time Process |
| S028 | 2014-07-02 | Normal 180 Day Track No User Fee |
| S027 | 2014-04-07 | Normal 180 Day Track |
| S026 | ||
| S025 | 2013-12-27 | 30-day Notice |
| S024 | 2013-08-09 | 30-day Notice |
| S023 | 2013-04-29 | Real-time Process |
| S022 | 2013-03-27 | 30-day Notice |
| S021 | ||
| S020 | 2012-08-17 | Real-time Process |
| S019 | 2012-06-19 | 30-day Notice |
| S018 | 2012-06-19 | Normal 180 Day Track |
| S017 | 2012-04-16 | Normal 180 Day Track |
| S016 | 2012-01-04 | Normal 180 Day Track |
| S015 | 2011-08-29 | 30-day Notice |
| S014 | ||
| S013 | 2011-06-20 | Normal 180 Day Track |
| S012 | 2011-03-01 | 30-day Notice |
| S011 | 2010-03-17 | Special (immediate Track) |
| S010 | 2010-03-02 | Normal 180 Day Track No User Fee |
| S009 | 2010-01-15 | Normal 180 Day Track |
| S008 | 2006-03-01 | Real-time Process |
| S007 | 2005-04-11 | Normal 180 Day Track |
| S006 | 2005-02-17 | Special (immediate Track) |
| S005 | 2003-12-22 | Normal 180 Day Track |
| S004 | 2003-11-05 | Real-time Process |
| S003 | 2002-10-01 | Real-time Process |
| S002 | 2001-11-29 | Normal 180 Day Track |
| S001 | 2000-06-28 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 10846835002393 | P990071 | 000 |
| 10846835002386 | P990071 | 000 |
| 10846835002379 | P990071 | 000 |
| 10846835000016 | P990071 | 005 |
| 10846835000085 | P990071 | 005 |
| 10846835012644 | P990071 | 017 |
| 10846835012637 | P990071 | 017 |
| 10846835009743 | P990071 | 017 |