PMA P990074S032
- Device
- NATRELLE SALINE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S032
- Product code
- FWM
- Decision date
- 2014-10-29
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- CHANGE IN THE BIOBURDEN TESTING METHOD AND SAMPLES USED FOR TESTING.
Current openFDA PMA Record#
- Device
- NATRELLE SALINE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S032
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2014-10-29
- Decision code
- OK30
- Date received
- 2014-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE BIOBURDEN TESTING METHOD AND SAMPLES USED FOR TESTING.