|
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 | S018 |
Date Received | 04/18/2014 |
Decision Date | 05/16/2014 |
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 ACCEPTANCE TO IMPLEMENT AN ADDITIONAL SUPPLIER TO PERFORM MACHINING OF THE ABLATION CATHETER HANDLE COMPONENTS. |