PMA P990074S026
- Device
- NATRELLE SALINE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S026
- Product code
- FWM
- Decision date
- 2013-06-12
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- ALLERGAN COSTA RICA FACILITY ADD MANUFACTURING SPACE (FLOOR SPACE) TO ITS PRODUCTION AREA IN THE SHELL SOAKING AND SCRUBBING ROOM (ROOM 2) AND GOWNING ROOM (ROOM 3) AND NEW HEPA FILTERS TO ROOM 2.
Current openFDA PMA Record#
- Device
- NATRELLE SALINE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S026
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2013-06-12
- Decision code
- OK30
- Date received
- 2013-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALLERGAN COSTA RICA FACILITY ADD MANUFACTURING SPACE (FLOOR SPACE) TO ITS PRODUCTION AREA IN THE SHELL SOAKING AND SCRUBBING ROOM (ROOM 2) AND GOWNING ROOM (ROOM 3) AND NEW HEPA FILTERS TO ROOM 2.