Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | TMX-2000 BPH THERMOTHERAPY SYSTEM |
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 | S007 |
Date Received | 07/14/2003 |
Decision Date | 04/28/2004 |
Withdrawal Date
|
12/20/2016 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A DESIGN CHANGE FOR THE RX-200 APPLICATOR FROM A 2.5 CM COIL TO A 2.0 CM COIL. |
|
|