INTACS PRESCRIPTION INSERTS
FDA premarket approval P980031/S009 · decided 2005-11-23
Approval details
- PMA number
- P980031
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTACS PRESCRIPTION INSERTS
- Generic name
- Implant, corneal, refractive
- Applicant
- Addition Technology
- Date received
- 2005-10-31
- Decision date
- 2005-11-23
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lombard, IL
- Statement
- TRANSFER OF NON-CRITICAL "AS/MANUFACTURED" DIMENSIONAL INSPECTIONS OF WIDTH, SYMMETRY, OUTER DIAMETER, ARC LENGTH, AND DRILL HOLE PLACEMENT FOR MACHINED INTACS PRESCRIPTION INSERTS FROM BIOTEST LABORATORIES TO OCULAR TECHNOLOGY INC.
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