INSTAT COLLAGEN ABSORBABLE HEMOSTAT
FDA premarket approval P830079/S011 · decided 1995-07-07
Approval details
- PMA number
- P830079
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INSTAT COLLAGEN ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 1995-06-13
- Decision date
- 1995-07-07
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL TO MARKET INSTAT COLLAGEN ABSORABLE HEMOSTAT (ALL SIZES) FOR ENDOSCOPIC PROCEDURES
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.