THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES
FDA premarket approval P060010/S012 · decided 2014-10-06
Approval details
- PMA number
- P060010
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES
- Generic name
- Stent, urethral, prostatic, semi-permanent
- Applicant
- Srs Medical
- Date received
- 2014-09-10
- Decision date
- 2014-10-06
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NZC
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- North Billerica, MA
- Statement
- UTILIZATION OF A LARGER EXISTING CLEANROOM WITHIN THE CURRENT MANUFACTURING FACILITY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CT3000Pro (K212830) | Srs Medical | 2021-12-21 |