COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN
FDA premarket approval P800022/S050 · decided 2003-03-11
Approval details
- PMA number
- P800022
- Supplement
- S050
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Allergan
- Date received
- 2001-05-16
- Decision date
- 2003-03-11
- Days to decision
- 664 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Goleta, CA
- Statement
- APPROVAL FOR COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN. THE INDICATIONS FOR USE ARE AS FOLLOWS: COSMODERM 1 HUMAN-BASED COLLAGEN AND COSMODERM 2 HUMAN-BASED COLLAGEN ARE INJECTED INTO THE SUPERFICIAL PAPILLARY DERMIS FOR CORRECTION OF SOFT TISSUE CONTOUR DEFICIENCIES, SUCH AS WRINKLES AND ACNE SCARS, AND COSMOPLAST HUMAN-BASED COLLAGEN IS INJECTED INTO THE MID TO DEEP DERMIS FOR CORRECTION OF SOFT TISSUE CONTOUR DEFICIENCIES, SUCH AS W
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