Atlas FDA

AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

FDA premarket approval P000053/S066 · decided 2016-08-03

Approval details

PMA number
P000053
Supplement
S066
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
Generic name
Device, incontinence, mechanical/hydraulic
Applicant
Boston Scientific Corp
Date received
2016-07-05
Decision date
2016-08-03
Days to decision
29 days
Decision code
OK30
Product code
EZY
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
Quality control changes related to InhibiZone formulation including reduction of test samples, change in detection method from HPLC to UPLC, and change in facility conducting test.

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