Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | DIPLOS MODEL 03 |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P820076 |
Supplement Number | S001 |
Date Received | 10/22/1984 |
Decision Date | 02/12/1986 |
Withdrawal Date
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08/05/2019 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
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