Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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Trade Name | Reclaim® DBS Therapy for Obsessive Compulsive Disorder (OCD) System |
Classification Name | deep brain stimulator for obsessive compulsive disorder (ocd) |
Generic Name | deep brain stimulator for obsessive compulsive disorder (ocd) |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
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HDE Number | H050003 |
Supplement Number | S289 |
Date Received | 08/29/2022 |
Decision Date | 01/08/2024 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the following: for p960009/s438, approval for: • model b35300 percept rc implantable neurostimulator (ins)• model rs6230 recharger kit (including the wr9230 recharger)• model a610 clinician programmer application (ppa) software (version 4. 0) • model a620 patient programmer application (cpa) (version 3. 0) • a90300 recharger application software (ras) (version 2. 0) • labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new percept rc system. For h020007/s329, approval for: • model b35300 percept rc implantable neurostimulator (ins)• model rs6230 recharger kit (including the wr9230 recharger)• model a610 clinician programmer application (ppa) software (version 4. 0) • model a620 patient programmer application (cpa) (version 3. 0) • a90300 recharger application software (ras) (version 2. 0) • dystonia kits (models 33th60, 33th76, and 33th69) • labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new percept rc system. For h050003/s289, approval for:• model a610 clinician programmer application (ppa) software (version 4. 0) for p840001/s527, approval for: • labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new percept rc system. |
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