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TMX-2000 BPH THERMOTHERAPY SYSTEM

FDA premarket approval P000043/S008 · decided 2003-12-22

Approval details

PMA number
P000043
Supplement
S008
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
TMX-2000 BPH THERMOTHERAPY SYSTEM
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
Boston Scientific Corp
Date received
2003-11-21
Decision date
2003-12-22
Days to decision
31 days
Decision code
APPR
Product code
MEQ
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
APPROVAL FOR THERMATRX, INC., NORTHBROOK, ILLINOIS AS AN ALTERNATE MANUFACTURING SITE FOR THE TEMPERATURE SENSOR AND TEMPERATURE REFERENCE PROBE.

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