• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHE SPANNER TEMPORARY PROSTATIC STENT
Classification Namestent, urethral, prostatic, semi-permanent
Generic Namestent, urethral, prostatic, semi-permanent
Applicant
SRS MEDICAL
76 treble cove road, #3
north billerica, MA 01862
PMA NumberP060010
Supplement NumberS010
Date Received05/20/2011
Decision Date07/28/2011
Product Code
NZC[ Registered Establishments with NZC ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A DESIGN CHANGE TO ADD AN ACCESS TETHER, CALLED THE SHORE LINE TO THE DEVICE.
-
-