|
Device | BARD ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 55 TECHNOLOGY DRIVE LOWELL, MA 01851 |
PMA Number | P000020 |
Supplement Number | S017 |
Date Received | 04/17/2014 |
Decision Date | 06/04/2014 |
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 IMPLEMENTATION OF A CHANGE TO LEAD-FREE SOLDER IN THECONNECTOR COMPONENT OF THE STINGER AND SCORPION2 ABLATION CATHETERS. |