TMX-2000 BPH THERMOTHERAPY SYSTEM
FDA premarket approval P000043/S006 · decided 2003-06-24
Approval details
- PMA number
- P000043
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TMX-2000 BPH THERMOTHERAPY SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Boston Scientific Corp
- Date received
- 2003-05-23
- Decision date
- 2003-06-24
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL TO EXTEND THE SHELF LIFE OF THE RX-200 TREATMENT CATHETER (A COMPONENT OF THE TMX-2000 BPH THERMOTHERAPY SYSTEM) TO THREE (3) YEARS.
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