|
Device | DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR |
Generic Name | implanted diaphragmatic/phrenic nerve Stimulator |
Regulation Number | 882.5830 |
Applicant | AVERY BIOMEDICAL DEVICES, INC. 61 MALL DR. COMMACK, NY 11725-5703 |
PMA Number | P860026 |
Supplement Number | S008 |
Date Received | 09/11/2002 |
Decision Date | 03/03/2003 |
Product Code |
GZE |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SELECTING A FINAL VALUE OF C22 AND C50 CAPACITORS DURING PRODUCTION TESTING BASED ON PARAMETERS MEASURED WITH CALIBRATED TEST EQUIPMENT TO RESULT IN PEAK OPERATING PERFORMANCE OF THE TRANSMITTER. |