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 IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
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 | S759 |
Date Received | 08/11/2023 |
Decision Date | 09/05/2023 |
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 Implementation of a new Vision System to detect presence of desiccant in the Electronic Module Assembly. |
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