INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
FDA premarket approval P980031/S002 · decided 2000-01-12
Approval details
- PMA number
- P980031
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
- Generic name
- Implant, corneal, refractive
- Applicant
- Addition Technology
- Date received
- 1999-12-23
- Decision date
- 2000-01-12
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lombard, IL
- Statement
- The 30-day notice requested the implementation of a qualified sampling plan for dimensional inspection of the product attributes: width, arc length, outside diameter, symmetry and hole placement.
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