|
Device | LUMOS & TACHOS & BELOS FAMILY OF ICDS & XELOS DR-T |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S029 |
Date Received | 07/03/2008 |
Decision Date | 12/24/2008 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE VISUAL INSPECTION CRITERIA FOR GLASS FEEDTHROUGHS USED IN BATTERIES. |