Helistaf® and Helitene® Absorbable Collagen Hemostatic Agents
FDA premarket approval P850010/S096 · decided 2021-04-28
Approval details
- PMA number
- P850010
- Supplement
- S096
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Helistaf® and Helitene® Absorbable Collagen Hemostatic Agents
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2021-03-31
- Decision date
- 2021-04-28
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Replacement of a packaging sealer, which has reached end of its life, with an identical model, at the Collagen Manufactunng Center (CMC) located at Plainsboro, NJ.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.