PMA P010055S005
- Device
- CORETHERM SYSTEM MICROWAVE THERMOTHERAPY
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S005
- Product code
- MEQ
- Decision date
- 2009-05-21
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY, WIESBADEN, GERMANY.
Current openFDA PMA Record#
- Device
- CORETHERM SYSTEM MICROWAVE THERMOTHERAPY
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S005
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2009-05-21
- Decision code
- APPR
- Date received
- 2009-04-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY, WIESBADEN, GERMANY.