PROSTALUND CORETHERM SYSTEM
FDA premarket approval P010055/S007 · decided 2014-01-29
Approval details
- PMA number
- P010055
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROSTALUND CORETHERM SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Prostalund AB
- Date received
- 2009-09-09
- Decision date
- 2014-01-29
- Days to decision
- 1603 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Se-223 63 Lund
- Statement
- APPROVAL FOR MODIFICATION OF THE INDICATIONS FOR USE AND ASSOCIATED MODIFICATIONS TO THE CATHETER, ANTENNA, AND TEMPERATURE PROBE FOR PATIENTS WITH PROSTATES SMALLER THAN CURRENTLY INDICATED. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CORETHERMACCESSORIES FOR SMALL PROSTATES AND IS INDICATED FOR USE TOGETHER WITH PROSTALUND CORETHERM /SE IN PATIENTS WITH GLANDS SIZE 20-50G AND WITH A PROSTATE LENGTH ¿25 MM.
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