PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
FDA premarket approval P010055/S001 · decided 2005-07-07
Approval details
- PMA number
- P010055
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Prostalund AB
- Date received
- 2004-07-30
- Decision date
- 2005-07-07
- Days to decision
- 342 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Se-223 63 Lund
- Statement
- APPROVAL FOR TECHNOLOGICAL MODIFICATIONS TO THE CORETHERM SYSTEM TO COMPLY WITH THE NEW EDITION OF IEC 6061-1-2 "MEDICAL ELECTRICAL EQUIPMENT - PART1: GENERAL REQUIREMENTS FOR SAFETY; ELECTROMAGNETIC COMPATIBILITY REQUIREMENTS AND TESTS" (2ND EDITION, 2001).
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