COLLACOTE & COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
FDA premarket approval P840062/S020 · decided 2010-06-22
Approval details
- PMA number
- P840062
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLACOTE & COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2010-05-24
- Decision date
- 2010-06-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- CHANGE IN MANUFACTURING EQUIPMENT.
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