FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Intraocular Lens
PMA: P980040
·
Supplement: S062
·
Decision Aug 25, 2015
Classifications
1
FEI Numbers
59
Registration Numbers
59
Basic Information
- Device Name
- Intraocular Lens
- Trade Name
- TECNIS TORIC 1-PIECE INTRAOCULAR LENS
- PMA Number
- P980040
- Supplement Number
- S062
- 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
- August 25, 2015
- Date Received
- April 2, 2015
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE POST-APPROVAL STUDYPROTOCOL.
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 |