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 the addition of an in-process inflation test for the insertion tool.
| Device | THE SPANNER TEMPORARY PROSTATIC STENT |
| Generic Name | Stent, Urethral, Prostatic, Semi-permanent |
| Applicant | SRS MEDICAL |
| Date Received | 2009-04-21 |
| Decision Date | 2009-05-19 |
| PMA | P060010 |
| Supplement | S005 |
| Product Code | NZC |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |