The 30-day notice requested that fda review a change in material from etr and mdx silicone rubber to liquid silicone rubber, and a change in the manufacturing process, from transfer molding to liquid injection molding, using an approved vendor. These changes apply to the fins, tines, and suture sleeve components of the passive plus(r) endocardial pacing leads.
| Device | PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | St. Jude Medical |
| Date Received | 1998-09-16 |
| Decision Date | 1998-10-08 |
| PMA | P960030 |
| Supplement | S004 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical 15900 Valley View Ct. p.o. Box 9221 sylmar, CA 91392-9221 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P960030 | | Original Filing |
| S077 |
2022-09-08 |
Real-time Process |
| S076 |
2022-07-14 |
30-day Notice |
| S075 |
2021-06-28 |
30-day Notice |
| S074 |
2021-03-12 |
30-day Notice |
| S073 |
2021-02-19 |
30-day Notice |
| S072 |
2020-11-25 |
30-day Notice |
| S071 |
2020-10-21 |
30-day Notice |
| S070 |
2020-08-11 |
Real-time Process |
| S069 |
2020-05-22 |
30-day Notice |
| S068 |
2020-02-27 |
30-day Notice |
| S067 |
2019-09-26 |
30-day Notice |
| S066 | | |
| S065 |
2018-11-30 |
30-day Notice |
| S064 |
2018-11-23 |
30-day Notice |
| S063 |
2018-11-20 |
30-day Notice |
| S062 |
2018-10-02 |
30-day Notice |
| S061 |
2018-10-01 |
30-day Notice |
| S060 |
2018-09-28 |
30-day Notice |
| S059 |
2018-07-02 |
30-day Notice |
| S058 |
2018-03-05 |
30-day Notice |
| S057 |
2018-02-27 |
30-day Notice |
| S056 |
2018-01-31 |
30-day Notice |
| S055 |
2018-01-26 |
30-day Notice |
| S054 |
2017-02-28 |
30-day Notice |
| S053 |
2017-02-24 |
30-day Notice |
| S052 |
2017-02-17 |
135 Review Track For 30-day Notice |
| S051 |
2017-02-10 |
30-day Notice |
| S050 |
2017-01-25 |
30-day Notice |
| S049 |
2016-12-13 |
30-day Notice |
| S048 |
2016-10-12 |
30-day Notice |
| S047 |
2016-09-27 |
135 Review Track For 30-day Notice |
| S046 | | |
| S045 |
2016-06-22 |
30-day Notice |
| S044 |
2016-04-12 |
30-day Notice |
| S043 |
2016-04-04 |
30-day Notice |
| S042 |
2016-01-21 |
30-day Notice |
| S041 |
2016-01-19 |
30-day Notice |
| S040 |
2015-10-26 |
135 Review Track For 30-day Notice |
| S039 |
2015-08-10 |
30-day Notice |
| S038 |
2013-09-05 |
30-day Notice |
| S037 |
2012-09-13 |
30-day Notice |
| S036 |
2012-04-03 |
30-day Notice |
| S035 |
2012-02-14 |
Real-time Process |
| S034 |
2011-11-30 |
135 Review Track For 30-day Notice |
| S033 |
2011-04-04 |
30-day Notice |
| S032 |
2010-08-16 |
Normal 180 Day Track No User Fee |
| S031 |
2010-05-20 |
Normal 180 Day Track |
| S030 |
2010-04-13 |
30-day Notice |
| S029 |
2009-12-24 |
30-day Notice |
| S028 |
2009-11-25 |
Normal 180 Day Track No User Fee |
| S027 |
2009-08-28 |
30-day Notice |
| S026 |
2009-06-10 |
30-day Notice |
| S025 |
2009-01-30 |
30-day Notice |
| S024 |
2008-10-29 |
30-day Notice |
| S023 |
2008-08-26 |
Normal 180 Day Track No User Fee |
| S022 |
2008-05-21 |
30-day Notice |
| S021 |
2008-02-01 |
Normal 180 Day Track No User Fee |
| S020 |
2008-01-17 |
Real-time Process |
| S019 |
2007-10-19 |
Normal 180 Day Track No User Fee |
| S018 |
2007-09-28 |
30-day Notice |
| S017 |
2007-09-24 |
30-day Notice |
| S016 |
2007-03-05 |
Real-time Process |
| S015 |
2007-02-26 |
135 Review Track For 30-day Notice |
| S014 |
2007-02-08 |
30-day Notice |
| S013 |
2005-09-09 |
Real-time Process |
| S012 |
2004-08-03 |
Normal 180 Day Track |
| S011 |
2004-07-16 |
Normal 180 Day Track No User Fee |
| S010 |
2003-02-11 |
Real-time Process |
| S009 |
2002-12-04 |
Real-time Process |
| S008 |
2000-11-16 |
Real-time Process |
| S007 |
2000-08-11 |
Normal 180 Day Track |
| S006 |
1999-07-02 |
135 Review Track For 30-day Notice |
| S005 |
1999-04-01 |
Normal 180 Day Track |
| S004 |
1998-09-16 |
30-day Notice |
| S003 |
1998-09-15 |
30-day Notice |
| S002 | | |
| S001 | | |
NIH GUDID Devices