INTACS CORNEAL IMPLANTS
FDA premarket approval P980031/S011 · decided 2012-12-19
Approval details
- PMA number
- P980031
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTACS CORNEAL IMPLANTS
- Generic name
- Implant, corneal, refractive
- Applicant
- Addition Technology
- Date received
- 2012-11-14
- Decision date
- 2012-12-19
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lombard, IL
- Statement
- OUTSOURCING OF THE INTACS SEGMENT THICKNESS AND PACKAGING COMPONENT INSPECTION ACTIVITIES.
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