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 LITHOTRIPTER TRANSPORTABLE (DLT) |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | Dornier MedTech America, Inc. 1155 ROBERTS BLVD. KENNESAW, GA 30144 |
PMA Number | P840008 |
Supplement Number | S052 |
Date Received | 08/09/1995 |
Decision Date | 10/05/1995 |
Reclassified Date
|
09/08/2000 |
Product Code |
LNS |
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 NEW MODEL LITHOTRIPTER, THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME DORNIER LITHOTRIPTER TRANSPORTABLE |
|
|