THE SPANNER TEMPORARY PROSTATIC STENT
FDA premarket approval P060010 · decided 2006-12-14
Approval details
- PMA number
- P060010
- Trade name
- THE SPANNER TEMPORARY PROSTATIC STENT
- Generic name
- Stent, urethral, prostatic, semi-permanent
- Applicant
- Srs Medical
- Date received
- 2006-03-14
- Decision date
- 2006-12-14
- Days to decision
- 275 days
- Decision code
- APPR
- Product code
- NZC
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- North Billerica, MA
- Statement
- APPROVAL FOR THE SPANNER TEMPORARY PROSTATIC STENT. THE DEVICE IS INTENDED FOR TEMPORARY USE (UP TO 30 DAYS) TO MAINTAIN URINE FLOW AND ALLOW VOLUNTARY URINATION IN PATIENTS FOLLOWING MINIMALLY INVASIVE TREATMENT FOR BENIGN PROSTATIC HYPERPLASIA (BPH) AND AFTER INITIAL POST-TREATMENT CATHETERIZATION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CT3000Pro (K212830) | Srs Medical | 2021-12-21 |