MORCHER ® EYEJET ® CTR
FDA premarket approval P010059/S010 · decided 2023-08-17
Approval details
- PMA number
- P010059
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MORCHER ® EYEJET ® CTR
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2023-07-24
- Decision date
- 2023-08-17
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Stuttgart
- Statement
- Configuration change to the gamma radiation sterilization.
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