INTACS PRESCRIPTION INSERTS
FDA premarket approval P980031/S005 · decided 2003-05-30
Approval details
- PMA number
- P980031
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTACS PRESCRIPTION INSERTS
- Generic name
- Implant, corneal, refractive
- Applicant
- Addition Technology
- Date received
- 2003-05-02
- Decision date
- 2003-05-30
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lombard, IL
- Statement
- IMPLEMENTING THE OUTSOURCING OF THE INSPECTION, CLEANING AND PACKAGING OPERATIONS FOR INTACS INSERTS TO THE QUALIFIED CONTRACT MANUFACTURER, BIOTEST LABORATORIES, INC.
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