CORETHERM SYSTEM MICROWAVE THERMOTHERAPY
FDA premarket approval P010055/S006 · decided 2009-06-08
Approval details
- PMA number
- P010055
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CORETHERM SYSTEM MICROWAVE THERMOTHERAPY
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Prostalund AB
- Date received
- 2009-04-02
- Decision date
- 2009-06-08
- Days to decision
- 67 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 CENOVA INNOVATION AND PRODUCTION AB IN MJOLBY, SWEDEN, WHERE CATHETER PACKAGING WILL BE PERFORMED.
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