PMA P950008S014
- Device
- Silikon 1000 Endotamponade
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S014
- Product code
- LWL
- Decision date
- 2018-06-07
- Classification
- Fluid, Intraocular
- Generic name
- Fluid, intraocular
- Approval order statement
- Approval for proposed labeling modifications.
Current openFDA PMA Record#
- Device
- Silikon 1000 Endotamponade
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S014
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2018-06-07
- Decision code
- APPR
- Date received
- 2018-05-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for proposed labeling modifications.