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 ST 53,SELOX ST 60,SELOX JT 45,SELOX JT 53,SETROX S 45,SETROX S53,SETROX S60,DEXTRUS 4135,DEXTRUS 4136,DETRUS 4137, |
Generic Name | Pulse generator, permanent, implantable |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S133 |
Date Received | 12/09/2013 |
Decision Date | 01/06/2014 |
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 | Yes |
Approval Order Statement TWO ADDITIONAL INJECTION MOLDING TOOLS USED TO MANUFACTURE THE SILICONE SLEEVES OF THE PACEMAKER LEADS. |
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