PMA P970034S005
- Device
- POSTERIOR CHAMBER INTRAOCULAR LENSES
- Applicant
- Aaren Scientific
- PMA number
- P970034
- Supplement
- S005
- Product code
- HQL
- Decision date
- 2000-03-27
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Approval for reducing the frequency of ethylene chlorohydrin residual testing from a quarterly basis to an annual basis.
Current openFDA PMA Record#
- Device
- POSTERIOR CHAMBER INTRAOCULAR LENSES
- Applicant
- Aaren Scientific
- PMA number
- P970034
- Supplement
- S005
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2000-03-27
- Decision code
- APPR
- Date received
- 2000-02-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for reducing the frequency of ethylene chlorohydrin residual testing from a quarterly basis to an annual basis.