COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
FDA premarket approval P810006/S034 · decided 2012-09-14
Approval details
- PMA number
- P810006
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Trade name
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2012-08-23
- Decision date
- 2012-09-14
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- CHANGE IN CHART RECORDING SYSTEM.
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