FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Intraocular Lens
PMA: P930014
·
Supplement: S077
·
Decision Feb 17, 2015
Classifications
1
FEI Numbers
59
Registration Numbers
59
Basic Information
- Device Name
- Intraocular Lens
- Trade Name
- ACRYSOF IQ TORIC IOLS
- PMA Number
- P930014
- Supplement Number
- S077
- Device Class
- FDA Class 3
- Product Code
- HQL
- Generic Name
- intraocular lens
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 17, 2015
- Date Received
- December 19, 2014
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: UPDATE THE TARGETED NUMBER OF SUBJECTS TO BE IMPLANTED FROM 415 TO 400.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQL | Intraocular Lens | FDA class 3 | Ophthalmic |