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 | AMS UROLUME ENDOPROSTHESIS |
Generic Name | STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P920023 |
Supplement Number | S031 |
Date Received | 07/03/2012 |
Decision Date | 08/02/2012 |
Withdrawal Date
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04/11/2016 |
Product Code |
MES |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE LABEL DATABASE SERVER AND A LABELING SOFTWARE REVISION TO THE NICELABEL SYSTEM. |
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