CARIDEX(TM) REMOVAL SYSTEM
FDA premarket approval P830035/S003 · decided 1987-11-25
Approval details
- PMA number
- P830035
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARIDEX(TM) REMOVAL SYSTEM
- Generic name
- SOLUTION, REMOVAL, CARRIES
- Applicant
- Indevus Pharmaceuticals, Inc.
- Date received
- 1986-06-06
- Decision date
- 1987-11-25
- Days to decision
- 537 days
- Decision code
- APPR
- Product code
- LMW
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Cranbury, NJ
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