|
Device | IntellaNav XP and IntellaNav 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 | S102 |
Date Received | 06/08/2017 |
Decision Date | 06/27/2017 |
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 Alternate vendor to manufacture the tube braid component used for the IntellaNav XP and IntellaNav MiFI XP Temperature Ablation Catheters. |