FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lens, Intraocular, Accommodative
PMA: P030002
·
Supplement: S006
·
Decision Mar 3, 2006
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Lens, Intraocular, Accommodative
- Trade Name
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS
- PMA Number
- P030002
- Supplement Number
- S006
- 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
- March 3, 2006
- Date Received
- October 20, 2005
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR UPDATED PHYSICIAN LABELING WITH 3-YEAR CLINICAL DATA.
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 |