This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for changes to the design of the distal anchor including molding the anchor flat, replacing the wire reinforcement with an increase in durometer of the silicone, and adding titanium dioxide as a white colorant.
| Device | THE SPANNER TEMPORARY PROSTATIC STENT |
| Generic Name | Stent, Urethral, Prostatic, Semi-permanent |
| Applicant | SRS MEDICAL |
| Date Received | 2009-10-16 |
| Decision Date | 2009-12-09 |
| PMA | P060010 |
| Supplement | S008 |
| Product Code | NZC |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SRS MEDICAL 76 Treble Cove Road, #3 north Billerica, MA 01862 |
| 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 |