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 | OPTIMIZER SMART MINI, INTELIO Programmer, OPTIhome Remote Patient Monitoring System, Universal GUARDIO |
Generic Name | Implantable pulse generator |
Applicant | Impulse Dynamics (USA), Inc. 50 Lake Center Executive Parkway 401 Route 73N, Bldg. 50 ste 100 Marlton, NJ 08053 |
PMA Number | P180036 |
Supplement Number | S013 |
Date Received | 04/06/2022 |
Decision Date | 12/02/2022 |
Product Code |
QFV |
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 changes made to the GUARDIO Charger as well as other related changes to device components to accommodate its use with the OPTIhome system. |
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