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 | BETA-CATH(TM) SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | BEST VASCULAR, INC 4350 INTERNATIONAL BOULEVARD NORCROSS, GA 30093 |
PMA Number | P000018 |
Supplement Number | S013 |
Date Received | 04/24/2001 |
Decision Date | 10/18/2001 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATION TO THE DESIGN OF THE TRANSFER DEVICE, THE ADDITION OF A TWIN TRANSPORT CASE TO THE TRANSPORT SYSTEM, A MODIFICATION TO THE SOURCE COLLECTION CONTAINER, AND A MODIFICATION TO THE FLUID COLLECTION BAG,K OF THE 30 MM AND 40 MM NOVOSTE BETA-CATH SYSTEMS. |
|
|