FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Material, Dressing, Surgical, Polylactic Acid
PMA: P840062
·
Supplement: S038
·
Decision Apr 28, 2014
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Material, Dressing, Surgical, Polylactic Acid
- Trade Name
- COLLACOTE/COLLATAPE/COLLA[LUG ABSORBABLE COLLAGEN WOUND DRESS
- PMA Number
- P840062
- Supplement Number
- S038
- Device Class
- FDA Class 3
- Product Code
- LPG
- Generic Name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Medical Specialty
- Unknown
- Advisory Committee
- Dental
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- April 28, 2014
- Date Received
- April 10, 2014
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ENHANCEMENTS FOR THE LYOPHILIZER CHAMBER VACUUM CONTROL.
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 |