FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Absorbable Collagen Hemostatic Agent With Thrombin
PMA: P170012
·
Supplement: S017
·
Decision May 21, 2019
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Absorbable Collagen Hemostatic Agent With Thrombin
- Trade Name
- Hemoblast Bellows
- PMA Number
- P170012
- Supplement Number
- S017
- Device Class
- FDA Class 3
- Product Code
- PMX
- Generic Name
- Absorbable collagen hemostatic agent with thrombin
- Regulation Number
- 878.4490
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- May 21, 2019
- Date Received
- April 22, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Removal of heavy metal analysis from the certificate of analysis (CoA) for pyrogen free water and change of dosimeter from radiochromic to alanine dosimeters.
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 |
|---|---|---|---|
| PMX | Absorbable Collagen Hemostatic Agent With Thrombin | FDA class 3 | General, Plastic Surgery |