PMA P990074S033

Device: NATRELLE SALINE BREAST IMPLANTS
Applicant: Allergan
PMA number: P990074
Supplement: S033
Product code: FWM
Decision date: 2016-10-07
Classification: Prosthesis, Breast, Inflatable, Internal, Saline
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Approval for adding a new mixing specification of ± 2.5 % (by weight) for theplatinum silicone catalyst (Part A) and cross-linked siloxane (Part B) weights, noting that weights vary based on the size of the production run to produce the standard dispersion (P/N 200-003) and the barrier dispersion (P/N 200-004) during the production of breast implant shells.

Current openFDA PMA Record#

Device: NATRELLE SALINE BREAST IMPLANTS
Applicant: Allergan
PMA number: P990074
Supplement: S033
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2016-10-07
Decision code: APPR
Date received: 2016-09-07
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for adding a new mixing specification of ± 2.5 % (by weight) for theplatinum silicone catalyst (Part A) and cross-linked siloxane (Part B) weights, noting that weights vary based on the size of the production run to produce the standard dispersion (P/N 200-003) and the barrier dispersion (P/N 200-004) during the production of breast implant shells.