|
Device | BLAZER II CARDIAC ABLATION CATHETER AND CABLE |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S051 |
Date Received | 03/23/2012 |
Decision Date | 04/19/2012 |
Product Code |
LPB |
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 IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT. |