|
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 | S106 |
Date Received | 10/30/2017 |
Decision Date | 12/01/2017 |
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 |
Approval Order Statement Update the BSC2000-2 cycle conducted in Chamber 5 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software, a replacement vacuum pump with an additional vacuum pump booster, and a new validation documentation structure used to support the system. |