Approval for the sweet tip(r) rx models 4143, 4144, 4145, 4243, 4244, and 4245 steroid-eluting, positive-fixation, porous tip, pacing leads. These devices are indicated for chronic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.
| Device | SWEET TIP(R) RX STEROID ELUTING LEAD |
| Classification Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1996-03-04 |
| Decision Date | 1998-10-02 |
| PMA | P960006 |
| Supplement | S |
| Product Code | NVN |
| Docket Number | 99M-1982 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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