|
Device | BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETERS & BLAZER PRIME HTD CARDIAC ABLATION CATHETER & STERILE CABLES |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St Paul, MN 55112 |
PMA Number | P920047 |
Supplement Number | S049 |
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. |