|
Device | EPT-1000 CARDIAC ABLATION SYSTEM |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S013 |
Date Received | 11/05/1999 |
Decision Date | 11/30/1999 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement The 30-Day Notice requested a change in the manufacturing (sterilization) process for therapeutic ablation catheters used with the EPT-1000 that will allow the use of alternate biological indicators with a reduced incubation time. |