INSTAT ABSORBABLE COLLAGEN HEMOSTAT
FDA premarket approval P830079/S014 · decided 2003-09-26
Approval details
- PMA number
- P830079
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INSTAT ABSORBABLE COLLAGEN HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2003-08-25
- Decision date
- 2003-09-26
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL FOR REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" STATEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSTAT ABSORBABLE COLLAGEN HEMOSTAT AND IS INDICATED FOR USE "IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMOLOGICAL SURGERY) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR OTHER CONVENTIONAL PROCEDURES IN INEFFECTIVE OR IMPRACTICAL. INSTAT HEMOSTAT CAN BE CUT TO SIZE FOR USE IN ENDOSCOPIC PROCEDURES."
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