THE SPANNER TEMPORARY PROSTATIC STENT
FDA premarket approval P060010/S007 · decided 2009-06-26
Approval details
- PMA number
- P060010
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE SPANNER TEMPORARY PROSTATIC STENT
- Generic name
- Stent, urethral, prostatic, semi-permanent
- Applicant
- Srs Medical
- Date received
- 2009-04-28
- Decision date
- 2009-06-26
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NZC
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- North Billerica, MA
- Statement
- APPROVAL FOR MODIFICATION OF THE SPANNER PROXIMAL TUBE ASSEMBLY TO REPLACE THE STAINLESS STEEL COIL WITH A HIGH DUROMETER SILICONE SLEEVE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CT3000Pro (K212830) | Srs Medical | 2021-12-21 |