BIOLON
FDA premarket approval P960011/S032 · decided 2019-08-05
Approval details
- PMA number
- P960011
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOLON
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2019-05-07
- Decision date
- 2019-08-05
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- Approval for material changes to the tip cap and syringe tip cap system over-closure for BIOLON®.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.