|
Device | THERMATRIX OFFICE THERMOTHERAPY SYSTEM (TMX-3000) |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P000043 |
Supplement Number | S017 |
Date Received | 05/15/2007 |
Decision Date | 06/14/2007 |
Withdrawal Date
|
12/20/2016 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENT A REPLACEMENT COMPONENT USED ON THE TMX-3000 SYSTEM?S MICROWAVE MODULE PRINTED CIRCUIT BOARD. |