FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C
FDA premarket approval P010059/S006 · decided 2017-01-26
Approval details
- PMA number
- P010059
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2016-08-02
- Decision date
- 2017-01-26
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Stuttgart
- Statement
- Approval for new private labeling for an alternative distributor.
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