HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
FDA premarket approval P850010/S074 · decided 2017-03-01
Approval details
- PMA number
- P850010
- Supplement
- S074
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2017-01-30
- Decision date
- 2017-03-01
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Acknowledge Integras revisions to Integras LifeSciences Standard Operating Procedure (SOP) QTM-10-007 - Design Output Variable, and Manufacturing Control Quality Assurance Levels, to align with the recently updated ISO 14971:2012 Medical devices - Application of risk management to medical devices.
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