SALINE FILLED BREAST IMPLANT
FDA premarket approval P990074/S003 · decided 2000-12-15
Approval details
- PMA number
- P990074
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SALINE FILLED BREAST IMPLANT
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2000-11-29
- Decision date
- 2000-12-15
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- 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.
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