Morcher Capsular Tension Ring
FDA premarket approval P010059/S008 · decided 2024-11-04
Approval details
- PMA number
- P010059
- Supplement
- S008
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Morcher Capsular Tension Ring
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2023-05-30
- Decision date
- 2024-11-04
- Days to decision
- 524 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Stuttgart
- Statement
- approval for change in supplier of the following critical components: Eyejet CTR Body, Push Button, Cartridge, Clamp and Rod
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