FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Intraocular Lens
PMA: P980040
·
Supplement: S179
·
Decision Dec 16, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Intraocular Lens
- Trade Name
- TECNIS SIMPLICITY Delivery System
- PMA Number
- P980040
- Supplement Number
- S179
- Device Class
- FDA Class 3
- Product Code
- HQL
- Generic Name
- intraocular lens
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 16, 2025
- Date Received
- November 21, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an increase in the maximum aeration phase load size for degassing of TECNIS 1-Piece intraocular lenses (IOL) with TECNIS SIMPLICITY Delivery System sterilized by Ethylene Oxide at AMO Groningen
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 |