PMA P150034S004

Device
Raindrop Near Vision Inlay
Applicant
Rvo 2.0, Inc. (D.B.A. Optics Medical)
PMA number
P150034
Supplement
S004
Product code
LQE
Decision date
2017-10-25
Classification
Implant, Corneal, Refractive
Generic name
Implant, corneal, refractive
Approval order statement
Removal of a redundant chemical evaluation for two incoming materials.

Current openFDA PMA Record#

Device
Raindrop Near Vision Inlay
Applicant
Rvo 2.0, Inc. (D.B.A. Optics Medical)
PMA number
P150034
Supplement
S004
Product code
LQE
Generic name
Implant, corneal, refractive
Decision date
2017-10-25
Decision code
OK30
Date received
2017-09-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Removal of a redundant chemical evaluation for two incoming materials.