PMA P980031S003
- Device
- INTACS CORNEAL RING SEGMENTS
- Applicant
- Addition Technology
- PMA number
- P980031
- Supplement
- S003
- Product code
- LQE
- Decision date
- 2000-03-17
- Classification
- Implant, Corneal, Refractive
- Generic name
- Implant, corneal, refractive
- Approval order statement
- The 30-day Notice requested the implementation of modifications made to the tumble polishing and final cleaning process used for the Intacs corneal ring segments.
Current openFDA PMA Record#
- Device
- INTACS CORNEAL RING SEGMENTS
- Applicant
- Addition Technology
- PMA number
- P980031
- Supplement
- S003
- Product code
- LQE
- Generic name
- Implant, corneal, refractive
- Decision date
- 2000-03-17
- Decision code
- OK30
- Date received
- 2000-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-day Notice requested the implementation of modifications made to the tumble polishing and final cleaning process used for the Intacs corneal ring segments.