FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Material, Dressing, Surgical, Polylactic Acid
PMA: P840062
·
Supplement: S009
·
Decision Sep 20, 2006
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Material, Dressing, Surgical, Polylactic Acid
- Trade Name
- COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING
- PMA Number
- P840062
- Supplement Number
- S009
- Device Class
- FDA Class 3
- Product Code
- LPG
- Generic Name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Medical Specialty
- Unknown
- Advisory Committee
- Dental
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 20, 2006
- Date Received
- September 30, 2005
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO FOR PACKAGING AND STERI-TECH, INC., SALINAS, PUERTO RICO FOR STERILIZATION.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPG | Material, Dressing, Surgical, Polylactic Acid | FDA class 3 | Unknown |