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 | S010 |
Date Received | 02/15/2001 |
Decision Date | 03/09/2001 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE MANUFACTURING METHOD USED IN CUTTING THE DELIVERY CATHETER, FROM A MANUAL TO AN AUTOMATED PROCESS. |
|
|