Helistat® Absorbable Collagen Hemostatic Agent
FDA premarket approval P850010/S117 · decided 2026-05-27
Approval details
- PMA number
- P850010
- Supplement
- S117
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Helistat® Absorbable Collagen Hemostatic Agent
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2026-04-27
- Decision date
- 2026-05-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- an extension of Dirty Hold Time (DHT) for equipment used in cutting collagen during the manufacture of absorbable collagen products, and the installation of a new Clean Compressed Air Point of Use utility in the alternative ISO 8 Cleanroom
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.