|
Device | CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S031 |
Date Received | 09/19/2011 |
Decision Date | 11/17/2011 |
Product Code |
LPB |
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 THE INTERNAL GLUE FLAP AND THE CARTON END CLOSURE CHANGES TO THE PACKAGING DESIGN. |