UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S065 · decided 2015-10-29
Approval details
- PMA number
- P970008
- Supplement
- S065
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UROLOGIX TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2015-09-10
- Decision date
- 2015-10-29
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT SPECTRUM PLASTICS GROUP IN MINNEAPOLIS, MINNESOTA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.