CORETHERM SYSTEM MICROWAVE THERMOTHERAPY
FDA premarket approval P010055/S005 · decided 2009-05-21
Approval details
- PMA number
- P010055
- Supplement
- S005
- 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
- 2009-05-21
- Days to decision
- 49 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 STERIGENICS GERMANY, WIESBADEN, GERMANY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.