PMA P020056S029
- Device
- NATRELLE SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S029
- Product code
- FTR
- Decision date
- 2015-01-16
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: RE-OP PHASE PROTOCOL AS A NEW POST-APPROVAL STUDY REQUIREMENT.
Current openFDA PMA Record#
- Device
- NATRELLE SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S029
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2015-01-16
- Decision code
- APPR
- Date received
- 2014-10-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: RE-OP PHASE PROTOCOL AS A NEW POST-APPROVAL STUDY REQUIREMENT.