|
Device | SALINE FILLED BREAST IMPLANT |
Generic Name | Prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P990074 |
Supplement Number | S003 |
Date Received | 11/29/2000 |
Decision Date | 12/15/2000 |
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 THE PRODUCT LAL TESTING FROM A RELEASE TEST FOR EVERY STERILIZATION LOT, TO A MANUFACTURING CHANGE CONTROL TOOL USED FOR PROCESS AND MATERIAL CHANGES. THERE WILL BE NO ADVERSE EFFECT TO THE DEVICE AS A RESULT OF CHANGING THE LAL TESTING FROM A RELEASE TEST TO A QUALIFICATION TEST. HISTORICAL RECORDS OF LAL TESTING ON FINISHED PRODUCT DEMONSTRATE THE PRODUCT MANUFACTURING PROCESS IS CONTROLLED AND PREDICTABLE, DELIVERING AN ENDOTOXIN-FREE PRODUCT. |