|
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 | S086 |
Date Received | 09/10/2015 |
Decision Date | 10/13/2015 |
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 ADDITION OF A VACUUM PUMP ANTI-SURGE DEVICE TO THE EXISTING CHAMBER 1 EQUIPMENT AT THE CONTRACT STERILIZER. |