PROSTALUND OPERATIONS AB CORETHERM SYSTEM MICROWAVE THERMOTHERAPY
FDA premarket approval P010055/S003 · decided 2006-12-21
Approval details
- PMA number
- P010055
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROSTALUND OPERATIONS AB CORETHERM SYSTEM MICROWAVE THERMOTHERAPY
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Prostalund AB
- Date received
- 2006-11-22
- Decision date
- 2006-12-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Se-223 63 Lund
- Statement
- CHANGE IN THE MATERIAL USED IN THE TIP OF THE CATHETER COMPONENT OF THE DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.