MORCHER Capsular Tension Ring, EYEJET CTR, MORCHER Injector
FDA premarket approval P010059/S007 · decided 2023-09-06
Approval details
- PMA number
- P010059
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MORCHER Capsular Tension Ring, EYEJET CTR, MORCHER Injector
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2022-09-14
- Decision date
- 2023-09-06
- Days to decision
- 357 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Stuttgart
- Statement
- Approval for expansion of the Capsular Tension Ring device family to include the new Type 20C Model.
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