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TMX-2000 BPH THERMOTHERAPY SYSTEM

FDA premarket approval P000043/S001 · decided 2002-05-23

Approval details

PMA number
P000043
Supplement
S001
Supplement type
Normal 180 Day Track
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
2001-12-20
Decision date
2002-05-23
Days to decision
154 days
Decision code
APPR
Product code
MEQ
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT MANUFACTURING AND RESEARCH, INC., TUCSON, ARIZONA. THE RX-200 APPLICATOR WILL BE MANUFACTURED AT THIS FACILITY.

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