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THERMATRX TMX-2000 BPH THERMOTHERAPY SYSTEM

FDA premarket approval P000043/S014 · decided 2006-03-28

Approval details

PMA number
P000043
Supplement
S014
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
THERMATRX TMX-2000 BPH THERMOTHERAPY SYSTEM
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
Boston Scientific Corp
Date received
2006-03-02
Decision date
2006-03-28
Days to decision
26 days
Decision code
APPR
Product code
MEQ
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
APPROVAL FOR A TRANSFER OF PACKAGING SITE OF THE RECTAL PROBES TO AMERICAN MEDICAL SYSTEMS, MINNETONKA, MINNESOTA AND TO GENERATE PACKAGE LABELS IN HOUSE.

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