PMA P010018S003
- Device
- VIEWPOINT CK SYSTEM
- Applicant
- Refractec, Inc.
- PMA number
- P010018
- Supplement
- S003
- Product code
- MWD
- Decision date
- 2003-11-06
- Classification
- Ophthalmic
- Generic name
- Electrosurgical, radio frequency, refractive correction
- Approval order statement
- APPROVAL FOR UPDATING THE LABELING WITH THE 24 MONTH CLINICAL STUDY RESULTS.
Current openFDA PMA Record#
- Device
- VIEWPOINT CK SYSTEM
- Applicant
- Refractec, Inc.
- PMA number
- P010018
- Supplement
- S003
- Product code
- MWD
- Generic name
- Electrosurgical, radio frequency, refractive correction
- Decision date
- 2003-11-06
- Decision code
- APPR
- Date received
- 2003-07-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATING THE LABELING WITH THE 24 MONTH CLINICAL STUDY RESULTS.