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SRS MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12238513033428382SRS MEDICAL1Y2026-01-01321 Billerica Rd Chelmsford MA US 01824

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
482741572868999P060010THE SPANNER TEMPORARY PROSTATIC STENTNZC2006-12-14
482741807326717K882295FILLING VOLUME OPTIONLJH1988-09-13
482741999214997K881878CATHETER WITHDRAWAL UNITKNY1988-07-28
482741362732561K850169ERIS URO-DIAGNOSTIC SYSTEMFFG1985-04-22
482741485156477K212830CT3000ProFEN2021-12-21
482741665389269K070907INTERSON USB ULTRASOUND PROBE SYSTEMIYO2007-04-17
482741197599472K063447INSIGHT DISCOVERYIKN2007-08-16
482741906246307K033452CWAS 1000IKN2003-11-28
482741719561346K003367ORION PLATINUMHCC2001-01-04
482741017264040
482741308110448
482741702911397
482742040664356

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IKN22007-08-16
FEN12021-12-21
IYO12007-04-17
NZC 12006-12-14
HCC12001-01-04
LJH11988-09-13
KNY11988-07-28
FFG11985-04-22

PMA#

The Spanner Temporary Prostatic Stent

2022-10-07

SRS MEDICAL76 Treble Cove Road, #3north Billerica, MA 01862 PMA NumberP060010 Supplement NumberS013 Date Received06/22/2020 Decision Date10/07/2022 Product Code NZC  Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02643849 Supplement Typepanel...

PMN#

GUDID#