Atlas FDA

Spectrum Saline Breast Implants

FDA premarket approval P990075/S042 · decided 2017-08-09

Approval details

PMA number
P990075
Supplement
S042
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Spectrum Saline Breast Implants
Generic name
Prosthesis, breast, inflatable, internal, saline
Applicant
Mentor Worldwide, LLC
Date received
2017-07-12
Decision date
2017-08-09
Days to decision
28 days
Decision code
OK30
Product code
FWM
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Irvin, CA
Statement
Supplier change for Room Temperature Vulcanization (RTV) adhesive that is used in the assembly of Mentor® Spectrum® Saline Breast Implants with a kink valve. The current supplier location is Applied Silicone Corporation (ASC) located in Santa Paula, California. The new supplier location will be the Nusil Technology facility located in Carpinteria, California.

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510(k) clearances by this applicant

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