Atlas FDA

MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES

FDA premarket approval P990075/S036 · decided 2016-04-15

Approval details

PMA number
P990075
Supplement
S036
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
Generic name
Prosthesis, breast, inflatable, internal, saline
Applicant
Mentor Worldwide, LLC
Date received
2016-03-17
Decision date
2016-04-15
Days to decision
29 days
Decision code
OK30
Product code
FWM
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Irvin, CA
Statement
Update to the PROC000331 Packaging with Alloyd Heat Sealers and Tyvek Pouch to implement the use of Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices.

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