|
Device | EPT-1000XP CARDIAC ABLATION SYSTEM |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BOSTON SCIENTIFIC 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P020025 |
Supplement Number | S078 |
Date Received | 08/18/2015 |
Decision Date | 09/15/2015 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING MODIFICATIONS IN COMPLIANCE WITH ELECTRICAL AND EMC CONSENSUS STANDARDS. |