PMA P060010

Device: The Spanner Temporary Prostatic Stent
Applicant: Srs Medical
PMA number: P060010
Supplement: S013
Product code: NZC
Decision date: 2022-10-07
Generic name: Stent, urethral, prostatic, semi-permanent
Approval order statement: Approval for the Spanner Prostatic Stent. The device is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination for patients who are not candidates for pharmacologic, minimally invasive or surgical treatment of the prostate.

Current openFDA PMA Record#

Device: The Spanner Temporary Prostatic Stent
Applicant: Srs Medical
PMA number: P060010
Supplement: S013
Product code: NZC
Generic name: Stent, urethral, prostatic, semi-permanent
Decision date: 2022-10-07
Decision code: APPR
Date received: 2020-06-22
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Spanner Prostatic Stent. The device is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination for patients who are not candidates for pharmacologic, minimally invasive or surgical treatment of the prostate.