|
Device | MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS |
Generic Name | Prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P990074 |
Supplement Number | S008 |
Date Received | 07/23/2001 |
Decision Date | 08/08/2001 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN MANUFACTURING METHOD. THE CHANGE ADDS AN ALTERNATIVE METHOD FOR A CASTING PROCESS USING THE MOLDING METHOD OF THE STYLE 68 SALINE-FILLED BREAST IMPLANT SHELL COMPONENT USED IN THE FABRICATION OF SALINE-FILLED BREAST IMPLANTS. THERE WILL BE NO CHANGES TO COMPONENT SPECIFICATIONS, DESIGNED PERFORMANCE SPECIFICATIONS OF THE FINISHED DEVICE, OR TO THE PMA DESIGNATED PHYSICAL AND CHEMICAL SPECIFICATIONS OF THE FINISHED DEVICE. |