TMX-2000 (TM) BPH THERMOTHERAPY SYSTEM
FDA premarket approval P000043/S002 · decided 2002-01-11
Approval details
- PMA number
- P000043
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TMX-2000 (TM) BPH THERMOTHERAPY SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Boston Scientific Corp
- Date received
- 2001-12-20
- Decision date
- 2002-01-11
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE RX-200 APPLICATOR OF THE TMX-2000 BPH THERMOTHERAPY SYSTEM.
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