PMA P060010S012
- Device
- THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES
- Applicant
- Srs Medical
- Product code
- NZC
- Decision date
- 2014-10-06
- Generic name
- Stent, urethral, prostatic, semi-permanent
- Approval order statement
- UTILIZATION OF A LARGER EXISTING CLEANROOM WITHIN THE CURRENT MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES
- Applicant
- Srs Medical
- PMA number
- P060010
- Supplement
- S012
- Product code
- NZC
- Generic name
- Stent, urethral, prostatic, semi-permanent
- Decision date
- 2014-10-06
- Decision code
- OK30
- Date received
- 2014-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UTILIZATION OF A LARGER EXISTING CLEANROOM WITHIN THE CURRENT MANUFACTURING FACILITY.