PMA P980031S012
- Device
- INTACS CORNEAL IMPLANTS
- Applicant
- Addition Technology
- PMA number
- P980031
- Supplement
- S012
- Product code
- LQE
- Decision date
- 2013-06-03
- Classification
- Implant, Corneal, Refractive
- Generic name
- Implant, corneal, refractive
- Approval order statement
- TRANSFER OF DISTRIBUTION, PRODUCT RELEASE, SECONDARY LABELING AND PACKAGING, AND LIMITED SECONDARY LABELING AND SECONDARY PACKAGING REWORK OPERATIONS FROMTHE FIRMS CURRENT FACILITY TO ITS NEW FACILITY.
Current openFDA PMA Record#
- Device
- INTACS CORNEAL IMPLANTS
- Applicant
- Addition Technology
- PMA number
- P980031
- Supplement
- S012
- Product code
- LQE
- Generic name
- Implant, corneal, refractive
- Decision date
- 2013-06-03
- Decision code
- APPR
- Date received
- 2012-12-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Approval order statement
- TRANSFER OF DISTRIBUTION, PRODUCT RELEASE, SECONDARY LABELING AND PACKAGING, AND LIMITED SECONDARY LABELING AND SECONDARY PACKAGING REWORK OPERATIONS FROMTHE FIRMS CURRENT FACILITY TO ITS NEW FACILITY.