FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Lens, Intraocular, Accommodative
PMA: P030002
·
Supplement: S025
·
Decision Sep 15, 2011
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
- S025
- 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
- September 15, 2011
- Date Received
- August 18, 2011
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
REFURBISHMENT OF AN AUTOCLAVE STERILIZER.
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 |