- Device
- ProstaLund CoreTherm System Microwave Thermotherapy for BPH
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S011
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2021-06-30
- Decision code
- OK30
- Date received
- 2021-06-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change to move facilities including relocating critical analytical equipment.