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 | SELOX SR/ST/JT, SETROX S, AND DEXTRUS STEROID-ELUTING LEADS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S062 |
Date Received | 06/04/2008 |
Decision Date | 07/01/2011 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A SECOND MANUFACTURER OF THE STEROID COLLAR, AND SECOND SOURCE OF DEXAMETHASONE ACETATE (DXA) USED FOR PRODUCTION OF THE STEROID COLLAR. |
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