PMA P980031S004
- Device
- INTACS PRESCRIPTION INSERTS
- Applicant
- Addition Technology
- PMA number
- P980031
- Supplement
- S004
- Product code
- LQE
- Decision date
- 2001-10-11
- Classification
- Implant, Corneal, Refractive
- Generic name
- Implant, corneal, refractive
- Approval order statement
- APPROVAL FOR 0.275 MM AND 0.325 MM INTACS(TM) AS WELL AS FOR A NEW TRADE NAME, "INTACS(TM) PRESCRIPTION INSERTS."
Current openFDA PMA Record#
- Device
- INTACS PRESCRIPTION INSERTS
- Applicant
- Addition Technology
- PMA number
- P980031
- Supplement
- S004
- Product code
- LQE
- Generic name
- Implant, corneal, refractive
- Decision date
- 2001-10-11
- Decision code
- APPR
- Date received
- 2000-02-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR 0.275 MM AND 0.325 MM INTACS(TM) AS WELL AS FOR A NEW TRADE NAME, "INTACS(TM) PRESCRIPTION INSERTS."