ProstaLund CoreTherm System Microwave Thermotherapy for BPH
FDA premarket approval P010055/S011 · decided 2021-06-30
Approval details
- PMA number
- P010055
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ProstaLund CoreTherm System Microwave Thermotherapy for BPH
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Prostalund AB
- Date received
- 2021-06-03
- Decision date
- 2021-06-30
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Se-223 63 Lund
- Statement
- Manufacturing change to move facilities including relocating critical analytical equipment.
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