Allura Vaginal Stent

Stent, Vaginal

PMT Corporation

The following data is part of a premarket notification filed by Pmt Corporation with the FDA for Allura Vaginal Stent.

Pre-market Notification Details

Device IDK202542
510k NumberK202542
Device Name:Allura Vaginal Stent
ClassificationStent, Vaginal
Applicant PMT Corporation 1500 Park Road Chanhassen,  MN  55317
ContactMatt Cree
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeKXP  
CFR Regulation Number884.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-09-02
Decision Date2020-09-30

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