|
Device | The Spanner Temporary Prostatic Stent |
Generic Name | Stent, urethral, prostatic, semi-permanent |
Applicant | SRS MEDICAL 76 TREBLE COVE ROAD, #3 NORTH BILLERICA, MA 01862 |
PMA Number | P060010 |
Supplement Number | S013 |
Date Received | 06/22/2020 |
Decision Date | 10/07/2022 |
Product Code |
NZC |
Docket Number | 22M-2543 |
Notice Date | 10/17/2022 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT02643849
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Spanner Prostatic Stent. The device 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |