PMA P960011S032
- Device
- BIOLON
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S032
- Product code
- LZP
- Decision date
- 2019-08-05
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Approval for material changes to the tip cap and syringe tip cap system over-closure for BIOLON®.
Current openFDA PMA Record#
- Device
- BIOLON
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S032
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2019-08-05
- Decision code
- APPR
- Date received
- 2019-05-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for material changes to the tip cap and syringe tip cap system over-closure for BIOLON®.