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 |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS053 Date Received02/16/2022 Decision Date03/15/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-16 |
| Decision Date | 2022-03-15 |
| PMA | P990071 |
| Supplement | S053 |
| 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 NumberS053 Date Received02/16/2022 Decision Date03/15/2022 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 the Transfer Of Quality Inspection For The SmartAblate Irrigation Tubing Set From BWI Irwindale To Venusa De Mexico S. De R.L De C.V, DBA Lake Region Medical (LRM), A Previously Approved Supplier |
| 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 |