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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceSPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE
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 NumberS003
Date Received01/12/2009
Decision Date03/10/2009
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 to add 45 degree curve in the distal portion of the stent.
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