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 | Macroplastique Implants |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | UROPLASTY, LLC 5420 FELTL ROAD MINNETONKA, MN 55343 |
PMA Number | P040050 |
Supplement Number | S012 |
Date Received | 04/17/2019 |
Decision Date | 07/15/2019 |
Product Code |
LNM |
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 modified formulation of the polymer resin used in the syringe barrel. |
|
|