PMA P010055S001
- Device
- PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S001
- Product code
- MEQ
- Decision date
- 2005-07-07
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order 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).
Current openFDA PMA Record#
- Device
- PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S001
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2005-07-07
- Decision code
- APPR
- Date received
- 2004-07-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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).