|
Device | NAVISTAR RMT; NAVISTAR RMT DS CATHETER |
Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Regulation Number | 870.1220 |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990025 |
Supplement Number | S051 |
Date Received | 11/28/2016 |
Decision Date | 07/17/2017 |
Product Code |
DRF |
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 | No |
Approval Order Statement Approval for transfer of the extrusion process for a subcomponent of the catheters from the Cordis Miami facility to the Webster Juarez manufacturing facility. |