|
Device | SmartAblate Irrigation Tubing Set |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990071 |
Supplement Number | S059 |
Date Received | 01/19/2024 |
Decision Date | 02/19/2024 |
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 that Limulus Amoebocyte Lysate (LAL) tests for endotoxins be performed prior to sterilization |