The Spanner Temporary Prostatic Stent
FDA premarket approval P060010/S013 · decided 2022-10-07
Approval details
- PMA number
- P060010
- Supplement
- S013
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- The Spanner Temporary Prostatic Stent
- Generic name
- Stent, urethral, prostatic, semi-permanent
- Applicant
- Srs Medical
- Date received
- 2020-06-22
- Decision date
- 2022-10-07
- Days to decision
- 837 days
- Decision code
- APPR
- Product code
- NZC
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- North Billerica, MA
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CT3000Pro (K212830) | Srs Medical | 2021-12-21 |