|
Device | INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS |
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 | S066 |
Date Received | 12/17/2014 |
Decision Date | 01/15/2015 |
Product Code |
OAD |
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 OF MANUFACTURING CHANGES CONSISTING OF A NEW FIXTURE AND IN-PROCESS TESTING EQUIPMENT FOR THE INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS. |