PMA P060010S005

Device
THE SPANNER TEMPORARY PROSTATIC STENT
Applicant
Srs Medical
PMA number
P060010
Supplement
S005
Product code
NZC
Decision date
2009-05-19
Generic name
Stent, urethral, prostatic, semi-permanent
Approval order statement
APPROVAL FOR THE ADDITION OF AN IN-PROCESS INFLATION TEST FOR THE INSERTION TOOL.

Current openFDA PMA Record#

Device
THE SPANNER TEMPORARY PROSTATIC STENT
Applicant
Srs Medical
PMA number
P060010
Supplement
S005
Product code
NZC
Generic name
Stent, urethral, prostatic, semi-permanent
Decision date
2009-05-19
Decision code
APPR
Date received
2009-04-21
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR THE ADDITION OF AN IN-PROCESS INFLATION TEST FOR THE INSERTION TOOL.