OPHTEC-STABLEYES CAPSULAR TENSION RING
FDA premarket approval P030023/S002 · decided 2012-03-12
Approval details
- PMA number
- P030023
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPHTEC-STABLEYES CAPSULAR TENSION RING
- Generic name
- Ring, endocapsular
- Applicant
- Ophtec BV
- Date received
- 2012-01-05
- Decision date
- 2012-03-12
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- APPROVAL FOR A NEW SUPPLIER OF A CRITICAL RAW MATERIAL.
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