|
Device | INTELLANAV™ ST Ablation Catheter, BLAZER™ II Temperature Ablation Catheter, BLAZER ™ II HTD Temperature Ablation Cathete |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S128 |
Date Received | 08/22/2022 |
Decision Date | 09/21/2022 |
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 Modified adhesive curing process and parameters. |