THE SPANNER TEMPORARY PROSTATIC STENT
FDA premarket approval P060010/S005 · decided 2009-05-19
Approval details
- PMA number
- P060010
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THE SPANNER TEMPORARY PROSTATIC STENT
- Generic name
- Stent, urethral, prostatic, semi-permanent
- Applicant
- Srs Medical
- Date received
- 2009-04-21
- Decision date
- 2009-05-19
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NZC
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- North Billerica, MA
- Statement
- APPROVAL FOR THE ADDITION OF AN IN-PROCESS INFLATION TEST FOR THE INSERTION TOOL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CT3000Pro (K212830) | Srs Medical | 2021-12-21 |