COLLASTAT INSTAT ABSORABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P810006/S057 · decided 2014-11-18
Approval details
- PMA number
- P810006
- Supplement
- S057
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLASTAT INSTAT ABSORABLE COLLAGEN HEMOSTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2014-10-21
- Decision date
- 2014-11-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- UPDATING THE OPERATIONAL PARAMETERS OF A SEALING MACHINE USED IN THE COLLAGEN AREA AT INTEGRA NEUROSCIENCES FACILITY IN ANASCO, PUERTO RICO FOR THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.