INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
FDA premarket approval P980031/S001 · decided 1999-11-29
Approval details
- PMA number
- P980031
- Supplement
- S001
- 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
- 1999-11-03
- Decision date
- 1999-11-29
- Days to decision
- 26 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 the View Engineering voyage Model V1212 Dimensional Non-contact Measurement system for the inspection of thickness, width and symmetry of the Intacs(TM) (Intrastromal Corneal Ring Segements).
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