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. |
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Device | THE SPANNER TEMPORARY PROSTATIC STENT |
Generic Name | Stent, urethral, prostatic, semi-permanent |
Applicant | SRS MEDICAL 76 TREBLE COVE ROAD, #3 NORTH BILLERICA, MA 01862 |
PMA Number | P060010 |
Supplement Number | S008 |
Date Received | 10/16/2009 |
Decision Date | 12/09/2009 |
Product Code |
NZC |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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