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THERMATRX TMX-3000 OFFICE THERMOTHERAPY SYSTEM

FDA premarket approval P000043/S019 · decided 2007-08-03

Approval details

PMA number
P000043
Supplement
S019
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
THERMATRX TMX-3000 OFFICE THERMOTHERAPY SYSTEM
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
Boston Scientific Corp
Date received
2007-07-10
Decision date
2007-08-03
Days to decision
24 days
Decision code
OK30
Product code
MEQ
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
MOVE A MANUFACTURING PROCESS FROM A CONTRACT MANUFACTURER IN SALT LAKE CITY, UTAH, TO THE FINAL ACCEPTANCE ACTIVITY SITE AT AMERICAN MEDICAL SYSTEMS, MINNETONKA, MINNESOTA.

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