DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM

FDA Premarket Approval P970044 S002

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.

Pre-market Approval Supplement Details

Approval for a mobile/transportable urowave(r).

DeviceDORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
Generic NameSystem, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
ApplicantDornier MedTech America, Inc.
Date Received1998-06-30
Decision Date1998-07-10
PMAP970044
SupplementS002
Product CodeMEQ 
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Dornier MedTech America, Inc. 1155 Roberts Blvd. kennesaw, GA 30144

Supplemental Filings

Supplement NumberDateSupplement Type
P970044Original Filing
S003 1999-02-02 Normal 180 Day Track
S002 1998-06-30 Real-time Process
S001 1998-06-15 Real-time Process

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