THE SPANNER TEMPORARY PROSTATIC STENT
FDA premarket approval P060010/S010 · decided 2011-07-28
Approval details
- PMA number
- P060010
- Supplement
- S010
- 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
- 2011-05-20
- Decision date
- 2011-07-28
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- NZC
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- North Billerica, MA
- Statement
- APPROVAL FOR A DESIGN CHANGE TO ADD AN ACCESS TETHER, CALLED THE SHORE LINE TO THE DEVICE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CT3000Pro (K212830) | Srs Medical | 2021-12-21 |