PROSTALUND CORETHERM SYSTEM AND PROSTALAND CORETHERM ACCESSORIES
FDA premarket approval P010055/S009 · decided 2014-07-30
Approval details
- PMA number
- P010055
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROSTALUND CORETHERM SYSTEM AND PROSTALAND CORETHERM ACCESSORIES
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Prostalund AB
- Date received
- 2014-02-21
- Decision date
- 2014-07-30
- Days to decision
- 159 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Se-223 63 Lund
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORIFICE MEDICAL AB IN YSTAD, SWEDEN.
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