|
Device | ICS 3000 IMPLANT MODULE AUTOMATED TEST |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P820076 |
Supplement Number | S025 |
Date Received | 06/16/2011 |
Decision Date | 02/24/2012 |
Withdrawal Date
|
08/05/2019 |
Product Code |
LWP |
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 ADDITION OF AN AUTOMATED PRODUCTION TEST PROCESS. |