PMA P150034S001

Device
REVISION OPTICS RAINDROP NEAR VISION INLAY
Applicant
Rvo 2.0, Inc. (D.B.A. Optics Medical)
PMA number
P150034
Supplement
S001
Product code
LQE
Decision date
2016-12-27
Classification
Implant, Corneal, Refractive
Generic name
Implant, corneal, refractive
Approval order statement
Approval of the protocol for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device
REVISION OPTICS RAINDROP NEAR VISION INLAY
Applicant
Rvo 2.0, Inc. (D.B.A. Optics Medical)
PMA number
P150034
Supplement
S001
Product code
LQE
Generic name
Implant, corneal, refractive
Decision date
2016-12-27
Decision code
APPR
Date received
2016-07-29
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the protocol for the post-approval study (PAS) protocol.