PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
FDA premarket approval P010055 · decided 2002-12-23
Approval details
- PMA number
- P010055
- Trade name
- PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Prostalund AB
- Date received
- 2001-09-10
- Decision date
- 2002-12-23
- Days to decision
- 469 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Se-223 63 Lund
- Statement
- APPROVAL FOR THE PROSTALUND CORETHERM MICROWAVE THERMOTHERAPY SYSTEM. THE PROSTALUND CORETHERM IS A NON-SURGICAL, MINIMALLY INVASIVE DEVICE INTENDED TO RELIEVE SYMPTOMS ASSOCIATED WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) BYE PROSTALUND FEEDBACK TREATMENT (PLFT), AND IS INDICATED FOR MEN WITH PROSTATE SIZE OF 30 TO 100G AND PROSTATIC URETHRA LENGTH >= 35 MM.
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