THERMATIX OFFICE THERMO THERAPY SYSTEM
FDA premarket approval P000043/S013 · decided 2006-02-27
Approval details
- PMA number
- P000043
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THERMATIX OFFICE THERMO THERAPY SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Boston Scientific Corp
- Date received
- 2006-02-07
- Decision date
- 2006-02-27
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR A REVISION OF CATHETER LABELS AND THE ADDITION OF AN ENHANCED LABEL TO THE EXISTING LABELED STOCK.
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