PMA N13787S003
- Device
- ENUCLENE(R) OPHTHALMIC SOLUTION
- Applicant
- Alcon Research, Ltd.
- PMA number
- N13787
- Supplement
- S003
- Product code
- MSI
- Decision date
- 1999-12-10
- Generic name
- Solution, cleaning / lubricating, artificial eye
- Approval order statement
- Approval for the alternate manufacturing facility located at Alcon Laboratories, Inc., ASPEX Manufacturing Facility, 6201 South Freeway, Fort Worth, TX 76134.
Current openFDA PMA Record
- Device
- ENUCLENE(R) OPHTHALMIC SOLUTION
- Applicant
- Alcon Research, Ltd.
- PMA number
- N13787
- Supplement
- S003
- Product code
- MSI
- Generic name
- Solution, cleaning / lubricating, artificial eye
- Decision date
- 1999-12-10
- Decision code
- APPR
- Date received
- 1999-10-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- Approval for the alternate manufacturing facility located at Alcon Laboratories, Inc., ASPEX Manufacturing Facility, 6201 South Freeway, Fort Worth, TX 76134.