INTACS CORNEAL IMPLANTS
FDA premarket approval P980031/S012 · decided 2013-06-03
Approval details
- PMA number
- P980031
- Supplement
- S012
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- INTACS CORNEAL IMPLANTS
- Generic name
- Implant, corneal, refractive
- Applicant
- Addition Technology
- Date received
- 2012-12-12
- Decision date
- 2013-06-03
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lombard, IL
- Statement
- TRANSFER OF DISTRIBUTION, PRODUCT RELEASE, SECONDARY LABELING AND PACKAGING, AND LIMITED SECONDARY LABELING AND SECONDARY PACKAGING REWORK OPERATIONS FROMTHE FIRMS CURRENT FACILITY TO ITS NEW FACILITY.
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