|
Device | Medical Adhesive Model 6517 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P830060 |
Supplement Number | S090 |
Date Received | 09/22/2023 |
Decision Date | 01/19/2024 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Prince Sterilization Services LLC, 16 Montesano Road, Fairfield, NJ 07004-3310. Prince Sterilization Services LLC will conduct dry heat sterilization of the Medical Adhesive Model 6517, and the Medical Adhesive in the Lead Repair Kit Model 6946. |