BIOLON®
FDA premarket approval P960011/S034 · decided 2022-10-03
Approval details
- PMA number
- P960011
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOLON®
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2022-09-08
- Decision date
- 2022-10-03
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- Change to the concentration step in the manufacturing process.
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