PMA P980031S011
- Device
- INTACS CORNEAL IMPLANTS
- Applicant
- Addition Technology
- PMA number
- P980031
- Supplement
- S011
- Product code
- LQE
- Decision date
- 2012-12-19
- Classification
- Implant, Corneal, Refractive
- Generic name
- Implant, corneal, refractive
- Approval order statement
- OUTSOURCING OF THE INTACS SEGMENT THICKNESS AND PACKAGING COMPONENT INSPECTION ACTIVITIES.
Current openFDA PMA Record#
- Device
- INTACS CORNEAL IMPLANTS
- Applicant
- Addition Technology
- PMA number
- P980031
- Supplement
- S011
- Product code
- LQE
- Generic name
- Implant, corneal, refractive
- Decision date
- 2012-12-19
- Decision code
- OK30
- Date received
- 2012-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- OUTSOURCING OF THE INTACS SEGMENT THICKNESS AND PACKAGING COMPONENT INSPECTION ACTIVITIES.