PMA P040046S002
- Device
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S002
- Product code
- FTR
- Decision date
- 2013-06-12
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- 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 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S002
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- 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.