PMA P090022S016
- Device
- ENDOTOXIN TEST METHOD
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S016
- Product code
- HQL
- Decision date
- 2013-04-05
- Generic name
- intraocular lens
- Approval order statement
- REQUESTED THE USE OF A DIFFERENT ENDOTOXIN TEST METHOD.
Current openFDA PMA Record#
- Device
- ENDOTOXIN TEST METHOD
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S016
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2013-04-05
- Decision code
- OK30
- Date received
- 2013-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REQUESTED THE USE OF A DIFFERENT ENDOTOXIN TEST METHOD.