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 | CELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CELERITY 3D 85, CELERITY PILOT 75, CELERITY PILOT 85, COROX OTW-L 75-BP, |
Generic Name | pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) |
Applicant | BIOTRONIK, INC. 6024 jean road lake oswego, OR 97035 |
PMA Number | P070008 |
Supplement Number | S064 |
Date Received | 04/29/2015 |
Decision Date | 01/28/2016 |
Product Code |
NKE |
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 AN ALTERNATIVE DRUG ELUTION METHOD FOR STEROID LEADS. |
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