|
Device | EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S030 |
Date Received | 09/22/2005 |
Decision Date | 12/23/2005 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRONIC ASSEMBLY, BUFFALO GROVE, ILLINOIS. |