PMA P030053S036

Device

MEMORYGEl BREAST IMPLANTS

Applicant

Mentor Corp.

PMA number

P030053

Supplement

S036

Product code

FTR

Decision date

2017-05-08

Classification

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled

Generic name

Prosthesis, breast, noninflatable, internal, silicone gel-filled

Approval order statement

Approval for implementation of a CO2 shell soaking process as an alternative to the current isopropyl alcohol (IPA) shell soaking process for removal of primarily low molecular weight (LMW) siloxanes from high temperature vulcanized (HTV) round and shaped breast implant shells.

Summary

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