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 | Adapta, Versa, Sensia, Astra S DR MRI IPG, Astra S SR MRI IPG,Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR MRI I |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S711 |
Date Received | 03/21/2022 |
Decision Date | 03/29/2022 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modify test setups used for process monitoring of packaging. |
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