BIOLON(1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
FDA premarket approval P960011/S008 · decided 2002-04-01
Approval details
- PMA number
- P960011
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- BIOLON(1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2002-03-18
- Decision date
- 2002-04-01
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION AND FINAL CARTONING FACILITY LOCATED AT MEDICAL MANUFACTURING CORPORATION, ERIE, PENNSYLVANIA.
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