|
Device | AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment |
Generic Name | Device, incontinence, mechanical/hydraulic |
Regulation Number | 876.5280 |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P000053 |
Supplement Number | S121 |
Date Received | 06/11/2021 |
Decision Date | 07/08/2021 |
Product Code |
EZY |
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 Addition of two sterilization chambers to conduct ethylene oxide gas sterilization Cycle 101. |