|
Device | ADDITION OF ALTERNATE TUBING EXTRUDER |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S002 |
Date Received | 04/17/1997 |
Decision Date | 10/23/1997 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of an alternate tubing extrusion process for the Pellethane(R) 55D used in the ThinLine(TM) family of pacing leads. |