This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the spanner temporary prostatic stent. The device is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia (bph) and after initial post-treatment catheterization.
| Device | THE SPANNER TEMPORARY PROSTATIC STENT |
| Generic Name | Stent, Urethral, Prostatic, Semi-permanent |
| Applicant | SRS MEDICAL |
| Date Received | 2006-03-14 |
| Decision Date | 2006-12-14 |
| Notice Date | 2006-12-26 |
| PMA | P060010 |
| Supplement | S |
| Product Code | NZC |
| Docket Number | 06M-0529 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SRS MEDICAL 76 Treble Cove Road, #3 north Billerica, MA 01862 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060010 | Original Filing | |
| S013 | 2020-06-22 | Panel Track |
| S012 | ||
| S011 | 2013-04-24 | Normal 180 Day Track No User Fee |
| S010 | 2011-05-20 | Real-time Process |
| S009 | 2011-05-20 | 30-day Notice |
| S008 | 2009-10-16 | Real-time Process |
| S007 | 2009-04-28 | Real-time Process |
| S006 | 2009-04-27 | 30-day Notice |
| S005 | 2009-04-21 | Special (immediate Track) |
| S004 | 2009-03-16 | 30-day Notice |
| S003 | 2009-01-12 | Real-time Process |
| S002 | 2008-03-20 | 30-day Notice |
| S001 | 2007-09-20 | Normal 180 Day Track |