PMA P990075S019
- Device
- MENTOR SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S019
- Product code
- FWM
- Decision date
- 2008-07-28
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- APPROVAL FOR A NEW STANDARD AND MICRO INJECTION DOME (PORT) TEMPORARY USE ACCESSORY COMPONENT.
Current openFDA PMA Record#
- Device
- MENTOR SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S019
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2008-07-28
- Decision code
- APPR
- Date received
- 2008-01-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW STANDARD AND MICRO INJECTION DOME (PORT) TEMPORARY USE ACCESSORY COMPONENT.