FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Lens, Intraocular, Accommodative
PMA: P030002
·
Supplement: S018
·
Decision Feb 26, 2009
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Lens, Intraocular, Accommodative
- Trade Name
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS
- PMA Number
- P030002
- Supplement Number
- S018
- Device Class
- FDA Class 3
- Product Code
- NAA
- Generic Name
- Lens, intraocular, accommodative
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 26, 2009
- Date Received
- January 27, 2009
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
IMPLEMENTATION OF AN ALTERNATE COMPONENT CLEANING METHOD.
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 |