|
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. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S048 |
Date Received | 06/21/2011 |
Decision Date | 03/23/2012 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS. |