Approval for the flextend pacing leads models 4086, 4087, 4088, and fixation tool model 6616. The flextend pacing leads models 4086, 4087, and 4088 are indicated for chronic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.
| Device | FLEXTEND PACING LEADS MODELS 4086, 4087, 4088, AND FIXATIO NTOOL MODEL 6616 |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2001-07-11 |
| Decision Date | 2002-02-04 |
| PMA | P960006 |
| Supplement | S005 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P960006 | | Original Filing |
| S055 |
2022-11-01 |
30-day Notice |
| S054 |
2021-09-30 |
30-day Notice |
| S053 |
2021-09-01 |
30-day Notice |
| S052 |
2021-04-30 |
30-day Notice |
| S051 |
2021-03-08 |
30-day Notice |
| S050 |
2021-01-11 |
30-day Notice |
| S049 |
2019-03-13 |
30-day Notice |
| S048 |
2018-07-13 |
30-day Notice |
| S047 |
2018-03-26 |
30-day Notice |
| S046 |
2016-05-27 |
30-day Notice |
| S045 | | |
| S044 |
2015-06-22 |
30-day Notice |
| S043 |
2014-06-30 |
30-day Notice |
| S042 |
2014-04-22 |
30-day Notice |
| S041 |
2014-01-28 |
Real-time Process |
| S040 |
2013-08-29 |
30-day Notice |
| S039 |
2013-05-16 |
Real-time Process |
| S038 |
2013-03-19 |
Real-time Process |
| S037 |
2012-11-08 |
30-day Notice |
| S036 |
2012-10-02 |
30-day Notice |
| S035 |
2012-09-04 |
30-day Notice |
| S034 |
2012-06-19 |
30-day Notice |
| S033 |
2012-03-26 |
30-day Notice |
| S032 |
2012-01-24 |
30-day Notice |
| S031 |
2011-05-25 |
30-day Notice |
| S030 |
2011-04-01 |
30-day Notice |
| S029 |
2010-12-01 |
135 Review Track For 30-day Notice |
| S028 | | |
| S027 |
2010-09-21 |
30-day Notice |
| S026 |
2009-12-18 |
30-day Notice |
| S025 |
2009-12-16 |
30-day Notice |
| S024 | | |
| S023 | | |
| S022 |
2007-05-07 |
30-day Notice |
| S021 |
2006-04-13 |
30-day Notice |
| S020 |
2006-04-13 |
30-day Notice |
| S019 |
2005-11-09 |
30-day Notice |
| S018 | | |
| S017 |
2005-08-01 |
30-day Notice |
| S016 |
2005-07-05 |
30-day Notice |
| S015 |
2005-04-13 |
30-day Notice |
| S014 |
2005-02-24 |
30-day Notice |
| S013 |
2004-12-03 |
30-day Notice |
| S012 |
2004-10-21 |
30-day Notice |
| S011 | | |
| S010 |
2004-04-14 |
30-day Notice |
| S009 |
2004-01-13 |
30-day Notice |
| S008 |
2003-03-20 |
Real-time Process |
| S007 |
2002-11-13 |
30-day Notice |
| S006 | | |
| S005 |
2001-07-11 |
Normal 180 Day Track |
| S004 |
2000-08-21 |
Normal 180 Day Track |
| S003 |
1999-12-16 |
Normal 180 Day Track |
| S002 |
1998-10-29 |
Real-time Process |
| S001 |
1998-10-02 |
Normal 180 Day Track |
NIH GUDID Devices