|
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 | S025 |
Date Received | 06/05/2008 |
Decision Date | 06/27/2008 |
Withdrawal Date
|
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 VENDOR FOR THE PLASTIC INJECTION MOLDED PARTS OF THE DEVICE AND THE ADDITION OF AN IN-PROCESS PULL-OUT TEST TO THE CURRENT MANUFACTURING PROCEDURE. |