|
Device | PROTEGO FAMILY OF ICD LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S057 |
Date Received | 01/27/2014 |
Decision Date | 07/03/2014 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE DF4 VARIANTS OF THE CURRENTLY APPROVED ILESTO/IFORIAICDS/CRT-DS AND LINOXSMART ICD LEADS. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |