TMX-2000 BPH THERMOTHERAPY SYSTEM
FDA premarket approval P000043 · decided 2001-06-29
Approval details
- PMA number
- P000043
- Trade name
- TMX-2000 BPH THERMOTHERAPY SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Boston Scientific Corp
- Date received
- 2000-10-16
- Decision date
- 2001-06-29
- Days to decision
- 256 days
- Decision code
- APWD
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR THE TMX-2000(TM) BPH THERMOTHERAPY SYSTEM. THE DEVICE IS INDICATED AS A NON-SURGICAL DEVICE FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH OF 30 MM AND A TOTAL PROSTATE VOLUME BETWEEN 30 AND 100 CC.
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