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.
| Device | The Spanner Temporary Prostatic Stent |
| Generic Name | Stent, Urethral, Prostatic, Semi-permanent |
| Applicant | SRS MEDICAL76 Treble Cove Road, #3north Billerica, MA 01862 PMA NumberP060010 Supplement NumberS013 Date Received06/22/2020 Decision Date10/07/2022 Product Code NZC Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02643849 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2020-06-22 |
| Decision Date | 2022-10-07 |
| PMA | P060010 |
| Supplement | S013 |
| Product Code | NZC |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SRS MEDICAL 76 Treble Cove Road, #3 north Billerica, MA 01862 PMA NumberP060010 Supplement NumberS013 Date Received06/22/2020 Decision Date10/07/2022 Product Code NZC Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02643849 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement The Spanner Prostatic Stent Is Intended For Temporary Use (up To 30 Days) To Maintain Urine Flow And Allow Voluntary Urination For Patients Who Are Not Candidates For Pharmacologic, Minimally Invasive Or Surgical Treatment Of The Prostate. |
| 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 |