PMA P010055S007
- Device
- PROSTALUND CORETHERM SYSTEM
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S007
- Product code
- MEQ
- Decision date
- 2014-01-29
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order 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.
Current openFDA PMA Record#
- Device
- PROSTALUND CORETHERM SYSTEM
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S007
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2014-01-29
- Decision code
- APPR
- Date received
- 2009-09-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.