INTACS PRESCRIPTION INSERTS
FDA premarket approval P980031/S007 · decided 2007-08-21
Approval details
- PMA number
- P980031
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTACS PRESCRIPTION INSERTS
- Generic name
- Implant, corneal, refractive
- Applicant
- Addition Technology
- Date received
- 2004-05-19
- Decision date
- 2007-08-21
- Days to decision
- 1189 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lombard, IL
- Statement
- APPROVAL FOR PACKAGING OPERATIONS FOR THE INTACS PRESCRIPTION INSERTS TO BE TRANSFERRED TO THE SUNNYVALE, CALIFORNIA FACILITY.
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