COSMODERM AND COSMOPLAST HUMAN-BASED COLLAGEN
FDA premarket approval P800022/S052 · decided 2004-05-11
Approval details
- PMA number
- P800022
- Supplement
- S052
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COSMODERM AND COSMOPLAST HUMAN-BASED COLLAGEN
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Allergan
- Date received
- 2003-10-24
- Decision date
- 2004-05-11
- Days to decision
- 200 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Goleta, CA
- Statement
- APPROVAL FOR A NEW RAW MATERIAL SUPPLIER FOR THE HUMAN COLLAGEN COMPONENT OF COSMODERM AND COSMOPLAST (I.E., IMMUCOR/GAMMA BIOLOGICALS OF HOUSTON, TEXAS).
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