|
Device | Butylated Hydroxytoluene (BHT) |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S579 |
Date Received | 12/05/2023 |
Decision Date | 01/03/2024 |
Product Code |
NIK |
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 a second-tier supplier site change and a modification to the amount of the antioxidant Butylated Hydroxytoluene in a material used in the tip area of the X4 Flushing tool/wire guide |