UROLOGIC TARGIS SYSTEM
FDA premarket approval P970008/S002 · decided 1998-01-09
Approval details
- PMA number
- P970008
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UROLOGIC TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 1997-09-05
- Decision date
- 1998-01-09
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for a new manufacturing facility located at SeaMED Corp., 21621 30th ave., NE, Bothell, WA 98021.
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