PROSTATRON
FDA premarket approval P950014/S024 · decided 2005-02-23
Approval details
- PMA number
- P950014
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROSTATRON
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 2005-01-19
- Decision date
- 2005-02-23
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL TO CHANGE LOCATION BALLOON MATERIAL FROM LATEX TO SILICONE, TO CHANGE THE METHOD OF ATTACHING THE LOCATION BALLOON DUE TO THE NEW MATERIAL, AND TO REMOVE THE CURRENT LATEX SENSITIVITY CAUTION AND OTHER REFERENCES TO LATEX IN THE LABELING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.