PMA P060010S008

Device: THE SPANNER TEMPORARY PROSTATIC STENT
Applicant: Srs Medical
PMA number: P060010
Supplement: S008
Product code: NZC
Decision date: 2009-12-09
Generic name: Stent, urethral, prostatic, semi-permanent
Approval order statement: APPROVAL FOR CHANGES TO THE DESIGN OF THE DISTAL ANCHOR INCLUDING MOLDING THE ANCHOR FLAT, REPLACING THE WIRE REINFORCEMENT WITH AN INCREASE IN DUROMETER OF THE SILICONE, AND ADDING TITANIUM DIOXIDE AS A WHITE COLORANT.

Current openFDA PMA Record#

Device: THE SPANNER TEMPORARY PROSTATIC STENT
Applicant: Srs Medical
PMA number: P060010
Supplement: S008
Product code: NZC
Generic name: Stent, urethral, prostatic, semi-permanent
Decision date: 2009-12-09
Decision code: APPR
Date received: 2009-10-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE DESIGN OF THE DISTAL ANCHOR INCLUDING MOLDING THE ANCHOR FLAT, REPLACING THE WIRE REINFORCEMENT WITH AN INCREASE IN DUROMETER OF THE SILICONE, AND ADDING TITANIUM DIOXIDE AS A WHITE COLORANT.