Approval for addition of a new inspection step to the package sealing and sterile package assembly manufacturing procedures and additional clarifications to final package inspection for specific visual inspection procedure, including an inspection step for detecting wrinkles.
| Device | LIVEWIRE TC AND SAFIRE ABLATION CATHETERS |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | St. Jude Medical |
| Date Received | 2014-08-06 |
| Decision Date | 2014-09-05 |
| PMA | P960016 |
| Supplement | S048 |
| Product Code | LPB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical 14900 Minnetonka Ind Rd minnetonka, MN 55345 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P960016 | | Original Filing |
| S089 |
2022-11-14 |
30-day Notice |
| S088 |
2021-09-14 |
30-day Notice |
| S087 | | |
| S086 |
2021-01-13 |
Real-time Process |
| S085 |
2020-09-18 |
30-day Notice |
| S084 | | |
| S083 |
2020-05-06 |
30-day Notice |
| S082 |
2020-03-23 |
30-day Notice |
| S081 |
2020-03-19 |
30-day Notice |
| S080 |
2019-09-26 |
30-day Notice |
| S079 |
2019-06-24 |
Normal 180 Day Track No User Fee |
| S078 |
2019-04-26 |
30-day Notice |
| S077 |
2019-02-14 |
Normal 180 Day Track No User Fee |
| S076 |
2018-12-12 |
Special (immediate Track) |
| S075 |
2018-08-02 |
30-day Notice |
| S074 |
2018-03-05 |
30-day Notice |
| S073 |
2018-03-01 |
30-day Notice |
| S072 |
2018-02-12 |
30-day Notice |
| S071 |
2018-02-05 |
30-day Notice |
| S070 |
2017-10-19 |
30-day Notice |
| S069 | | |
| S068 |
2017-05-04 |
30-day Notice |
| S067 |
2016-08-12 |
30-day Notice |
| S066 |
2016-06-01 |
30-day Notice |
| S065 |
2016-04-21 |
30-day Notice |
| S064 |
2016-03-22 |
135 Review Track For 30-day Notice |
| S063 |
2016-03-14 |
30-day Notice |
| S062 |
2016-03-09 |
30-day Notice |
| S061 |
2016-02-19 |
30-day Notice |
| S060 |
2015-11-20 |
Real-time Process |
| S059 |
2015-10-30 |
Normal 180 Day Track No User Fee |
| S058 |
2015-10-19 |
30-day Notice |
| S057 |
2015-09-23 |
30-day Notice |
| S056 |
2015-08-21 |
Normal 180 Day Track No User Fee |
| S055 |
2015-06-25 |
Normal 180 Day Track |
| S054 |
2015-04-17 |
30-day Notice |
| S053 |
2015-03-06 |
30-day Notice |
| S052 |
2014-12-22 |
Special (immediate Track) |
| S051 |
2014-12-17 |
Real-time Process |
| S050 |
2014-11-07 |
Real-time Process |
| S049 |
2014-08-27 |
Real-time Process |
| S048 |
2014-08-06 |
Special (immediate Track) |
| S047 |
2014-07-01 |
Real-time Process |
| S046 |
2014-04-30 |
Normal 180 Day Track No User Fee |
| S045 |
2014-03-03 |
Real-time Process |
| S044 |
2013-11-27 |
Normal 180 Day Track |
| S043 |
2013-09-19 |
135 Review Track For 30-day Notice |
| S042 |
2013-02-04 |
135 Review Track For 30-day Notice |
| S041 |
2013-02-01 |
135 Review Track For 30-day Notice |
| S040 |
2012-12-17 |
Real-time Process |
| S039 |
2012-07-23 |
Real-time Process |
| S038 |
2011-11-22 |
30-day Notice |
| S037 |
2011-07-05 |
30-day Notice |
| S036 |
2010-11-10 |
30-day Notice |
| S035 |
2010-10-05 |
30-day Notice |
| S034 |
2010-09-30 |
Real-time Process |
| S033 |
2010-09-27 |
Real-time Process |
| S032 |
2010-08-12 |
30-day Notice |
| S031 |
2010-07-20 |
30-day Notice |
| S030 |
2010-07-14 |
30-day Notice |
| S029 |
2010-05-27 |
Special (immediate Track) |
| S028 |
2010-03-09 |
30-day Notice |
| S027 |
2009-10-30 |
30-day Notice |
| S026 |
2009-10-29 |
30-day Notice |
| S025 |
2009-10-28 |
30-day Notice |
| S024 |
2009-09-02 |
30-day Notice |
| S023 | | |
| S022 |
2008-01-28 |
Real-time Process |
| S021 | | |
| S020 |
2007-10-03 |
Real-time Process |
| S019 |
2007-08-07 |
Real-time Process |
| S018 |
2007-04-26 |
Real-time Process |
| S017 | | |
| S016 |
2006-04-07 |
Real-time Process |
| S015 | | |
| S014 |
2005-09-09 |
Normal 180 Day Track |
| S013 |
2003-09-10 |
Special (immediate Track) |
| S012 |
2003-07-15 |
Real-time Process |
| S011 |
2003-06-26 |
135 Review Track For 30-day Notice |
| S010 |
2003-03-05 |
Normal 180 Day Track |
| S009 |
2003-02-12 |
Real-time Process |
| S008 |
2002-08-08 |
Real-time Process |
| S007 |
2001-05-14 |
Normal 180 Day Track |
| S006 |
2000-08-22 |
Normal 180 Day Track |
| S005 |
2000-08-18 |
Normal 180 Day Track |
| S004 |
2000-03-30 |
Normal 180 Day Track |
| S003 |
1999-06-28 |
Normal 180 Day Track |
| S002 |
1999-05-20 |
Normal 180 Day Track |
| S001 |
1999-05-06 |
Real-time Process |
NIH GUDID Devices