|
Device | IntellaNav™ ST Ablation Catheter, Blazer™ II Temperature Ablation Catheter, Blazer™ II HTD Temperature Ablation Catheter |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S126 |
Date Received | 01/24/2022 |
Decision Date | 02/22/2022 |
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 Relocation of multiple ablation catheter family subassembly manufacturing processes within the Heredia, Costa Rica campus. |