UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH
FDA premarket approval P970008/S051 · decided 2010-07-16
Approval details
- PMA number
- P970008
- Supplement
- S051
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2010-07-02
- Decision date
- 2010-07-16
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- CHANGE IN THE SUPPLIER OF SOLDER USED IN THE MANUFACTURE OF THE TARGIS SHORT CATHETER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.