PMA P990074S053
- Device
- NATRELLE® Saline-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S053
- Product code
- FWM
- Decision date
- 2024-06-21
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- The 30 Day notice is to notify FDA of the commissioning of the new MO675 RODI Process Water System in the Costa Rica facility
Current openFDA PMA Record#
- Device
- NATRELLE® Saline-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S053
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2024-06-21
- Decision code
- OK30
- Date received
- 2024-05-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30 Day notice is to notify FDA of the commissioning of the new MO675 RODI Process Water System in the Costa Rica facility