PMA P960011S034
- Device
- BIOLON®
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S034
- Product code
- LZP
- Decision date
- 2022-10-03
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Change to the concentration step in the manufacturing process.
Current openFDA PMA Record#
- Device
- BIOLON®
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S034
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2022-10-03
- Decision code
- OK30
- Date received
- 2022-09-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the concentration step in the manufacturing process.