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 | DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | Dornier MedTech America, Inc. 1155 ROBERTS BLVD. KENNESAW, GA 30144 |
PMA Number | P970044 |
Supplement Number | S001 |
Date Received | 06/15/1998 |
Decision Date | 06/23/1998 |
Withdrawal Date
|
07/23/2002 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the removal of the External INterstitial Thermometry System from the Urowave(R). |
|
|