INSTAT COLLAGEN ABSORBABLE HEMOSTAT
FDA premarket approval P830079/S017 · decided 2007-11-28
Approval details
- PMA number
- P830079
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSTAT COLLAGEN ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2007-06-01
- Decision date
- 2007-11-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL FOR THE ADDITION OF THE MANUFACTURING FACILITY LOCATED IN NORTH YORKSHIRE, UNITED KINGDOM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.