BIOLON(TM) 1% SODIUM HYALURONATE
FDA premarket approval P960011/S006 · decided 2001-03-08
Approval details
- PMA number
- P960011
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOLON(TM) 1% SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2000-09-27
- Decision date
- 2001-03-08
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- APPROVAL TO CHANGE THE CLEANING IN PLACE AND STERILIZATION IN PLACE PROCESSES AND INTRODUCE AN EQUILIBRATION STEP IN THE MANUFACTURING OF BIOLON(TM).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.