PMA P060010S007

Device
THE SPANNER TEMPORARY PROSTATIC STENT
Applicant
Srs Medical
PMA number
P060010
Supplement
S007
Product code
NZC
Decision date
2009-06-26
Generic name
Stent, urethral, prostatic, semi-permanent
Approval order statement
APPROVAL FOR MODIFICATION OF THE SPANNER PROXIMAL TUBE ASSEMBLY TO REPLACE THE STAINLESS STEEL COIL WITH A HIGH DUROMETER SILICONE SLEEVE.

Current openFDA PMA Record#

Device
THE SPANNER TEMPORARY PROSTATIC STENT
Applicant
Srs Medical
PMA number
P060010
Supplement
S007
Product code
NZC
Generic name
Stent, urethral, prostatic, semi-permanent
Decision date
2009-06-26
Decision code
APPR
Date received
2009-04-28
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODIFICATION OF THE SPANNER PROXIMAL TUBE ASSEMBLY TO REPLACE THE STAINLESS STEEL COIL WITH A HIGH DUROMETER SILICONE SLEEVE.