PMA P150037

Device: CyPass Micro-Stent
Applicant: Alcon Research, Ltd.
PMA number: P150037
Supplement: S014
Product code: OGO
Decision date: 2020-04-09
Generic name: Intraocular pressure lowering implant
Approval order statement: Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the letter dated October 10, 2019 requesting that you continue the assessment of subjects implanted with the device for a minimum of 10 years to assess the long-term safety profile of the CyPass® System.

Current openFDA PMA Record#

Device: CyPass Micro-Stent
Applicant: Alcon Research, Ltd.
PMA number: P150037
Supplement: S014
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2020-04-09
Decision code: APPR
Date received: 2019-12-20
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) referenced above. The PAS protocol has been submitted to comply with the letter dated October 10, 2019 requesting that you continue the assessment of subjects implanted with the device for a minimum of 10 years to assess the long-term safety profile of the CyPass® System.