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 | EPT-1000 CARDIAC ABLATION SYSTEM |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St Paul, MN 55112 |
PMA Number | P920047 |
Supplement Number | S012 |
Date Received | 03/23/1999 |
Decision Date | 03/30/1999 |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new technique for bonding the proximal to distal segment of the catheters. |
|
|