Approval for the acuity steerable lead models 4554, 4555, and 4556. The guidant acuity steerable is-1 coronary venous, steroid-eluting, dual-electrode pace/sense leads are transvenous leads intended for chronic, left-ventricular pacing and sensing via the coronary veins when used in conjunction with a compatible pulse generator. Extended bipolar pacing and sensing is available using acuity steerable with an rv pace/sense/defibrillation lead or a bipolar rv pace/sense lead.
| Device | ACUITY STEERABLE LEAD SYSTEM |
| Classification Name | Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode |
| Generic Name | Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode |
| Applicant | GUIDANT CORP. |
| Date Received | 2005-10-14 |
| Decision Date | 2007-04-13 |
| Notice Date | 2007-04-19 |
| PMA | P050046 |
| Supplement | S |
| Product Code | OJX |
| Docket Number | 07M-0154 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | GUIDANT CORP. 4100 Hamline Avenue North st. Paul, MN 55112-5798 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050046 | | Original Filing |
| S032 |
2021-09-01 |
30-day Notice |
| S031 |
2021-03-08 |
30-day Notice |
| S030 |
2021-01-11 |
30-day Notice |
| S029 |
2018-07-13 |
30-day Notice |
| S028 |
2018-03-26 |
30-day Notice |
| S027 | | |
| S026 |
2015-06-22 |
30-day Notice |
| S025 |
2015-06-05 |
30-day Notice |
| S024 |
2014-07-25 |
30-day Notice |
| S023 |
2014-01-28 |
Real-time Process |
| S022 |
2013-11-18 |
30-day Notice |
| S021 |
2013-08-29 |
30-day Notice |
| S020 |
2013-08-19 |
30-day Notice |
| S019 |
2012-11-14 |
Real-time Process |
| S018 |
2012-11-08 |
30-day Notice |
| S017 |
2012-10-02 |
30-day Notice |
| S016 |
2012-09-04 |
30-day Notice |
| S015 |
2012-07-30 |
30-day Notice |
| S014 |
2012-03-26 |
30-day Notice |
| S013 |
2012-01-24 |
30-day Notice |
| S012 |
2011-12-02 |
Real-time Process |
| S011 |
2011-05-25 |
30-day Notice |
| S010 |
2011-04-01 |
30-day Notice |
| S009 |
2011-01-26 |
135 Review Track For 30-day Notice |
| S008 | | |
| S007 |
2010-08-23 |
30-day Notice |
| S006 |
2009-12-18 |
30-day Notice |
| S005 |
2009-12-16 |
30-day Notice |
| S004 |
2009-02-04 |
135 Review Track For 30-day Notice |
| S003 |
2008-08-01 |
30-day Notice |
| S002 |
2007-11-23 |
Real-time Process |
| S001 | | |
NIH GUDID Devices