|
Device | MENTOR SALINE-FILLED BREAST IMPLANTS |
Applicant | MENTOR WORLDWIDE LLC 33 Technology Drive Irvine, CA 92618 |
PMA Number | P990075 |
Supplement Number | S006 |
Date Received | 07/26/2001 |
Decision Date | 08/09/2001 |
Advisory Committee |
General & Plastic Surgery |
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 LAL TESTING TO BE DONE ON A SKIP LOT AUDIT BASIS EVERY SIX MONTHS. |