PROLIEVE THERMODILATATION SYSTEM
FDA premarket approval P030006/S025 · decided 2012-05-17
Approval details
- PMA number
- P030006
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROLIEVE THERMODILATATION SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2012-04-23
- Decision date
- 2012-05-17
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- CHANGE IN A THERMOCOUPLE WIRE JOINT MANUFACTURING PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.