PMA P000043

Device: THERMATRX OFFICE THERMOTHERAPY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P000043
Supplement: S022
Product code: MEQ
Decision date: 2013-09-18
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: CHANGE IN STERILIZATION MONITORING PROCESS, CHANGE IN THE ORDER OF LABELING, AND CHANGE IN POUCH ORIENTATION.

Current openFDA PMA Record#

Device: THERMATRX OFFICE THERMOTHERAPY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P000043
Supplement: S022
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2013-09-18
Decision code: OK30
Date received: 2013-08-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN STERILIZATION MONITORING PROCESS, CHANGE IN THE ORDER OF LABELING, AND CHANGE IN POUCH ORIENTATION.