|
Device | BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01 |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P820076 |
Supplement Number | S017 |
Date Received | 11/16/1994 |
Decision Date | 09/07/1995 |
Withdrawal Date
|
08/05/2019 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SWM 600 VERSION DO5U01 SOFTWARE MODULE FOR USE WITH THE MODEL PMS 600 PROGRAMMER |