MORCHER® Capsular Tension Rings
FDA premarket approval P010059/S011 · decided 2023-09-06
Approval details
- PMA number
- P010059
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MORCHER® Capsular Tension Rings
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2023-08-07
- Decision date
- 2023-09-06
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Stuttgart
- Statement
- Approval for improved instructions for use labeling.
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