PMA P060010S010

Device
THE SPANNER TEMPORARY PROSTATIC STENT
Applicant
Srs Medical
PMA number
P060010
Supplement
S010
Product code
NZC
Decision date
2011-07-28
Generic name
Stent, urethral, prostatic, semi-permanent
Approval order statement
APPROVAL FOR A DESIGN CHANGE TO ADD AN ACCESS TETHER, CALLED THE SHORE LINE TO THE DEVICE.

Current openFDA PMA Record#

Device
THE SPANNER TEMPORARY PROSTATIC STENT
Applicant
Srs Medical
PMA number
P060010
Supplement
S010
Product code
NZC
Generic name
Stent, urethral, prostatic, semi-permanent
Decision date
2011-07-28
Decision code
APPR
Date received
2011-05-20
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A DESIGN CHANGE TO ADD AN ACCESS TETHER, CALLED THE SHORE LINE TO THE DEVICE.