FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lens, Intraocular, Accommodative
PMA: P030002
·
Supplement: S001
·
Decision Aug 16, 2004
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Lens, Intraocular, Accommodative
- Trade Name
- CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMMODATING INTRAOCULAR LENS (IOL)
- PMA Number
- P030002
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- NAA
- Generic Name
- Lens, intraocular, accommodative
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 16, 2004
- Date Received
- June 28, 2004
- Supplement Type
- Real-Time Process
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATIONS TO THE PHYSICIAN'S LABELING.
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 |
|---|---|---|---|
| NAA | Lens, Intraocular, Accommodative | FDA class 3 | Ophthalmic |