MORCHER® EYEJET® CTR Single-Use Injector
FDA premarket approval P010059/S012 · decided 2024-03-01
Approval details
- PMA number
- P010059
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MORCHER® EYEJET® CTR Single-Use Injector
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2024-02-02
- Decision date
- 2024-03-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Stuttgart
- Statement
- a change to the ink used for printing on the outside of the Tyvek packaging lid
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