HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P850010/S043 · decided 2013-08-23
Approval details
- PMA number
- P850010
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2013-08-01
- Decision date
- 2013-08-23
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- CHANGE TO A COMPONENT SHIPPING CONTAINER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.