PMA P960011S002
- Device
- BIOLON TM
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S002
- Product code
- LZP
- Decision date
- 1999-07-01
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Approval for the use of a new packaging suite and for the use of a semi-automatic provess for assembly and labeling of the BioLon(TM) syringes.
Current openFDA PMA Record#
- Device
- BIOLON TM
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S002
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 1999-07-01
- Decision code
- APPR
- Date received
- 1999-03-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the use of a new packaging suite and for the use of a semi-automatic provess for assembly and labeling of the BioLon(TM) syringes.