PMA P850010S067
- Device
- HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S067
- Product code
- LMF
- Decision date
- 2016-03-29
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Approval for a change to the collagen processing equipment cleaning protocol.
Current openFDA PMA Record#
- Device
- HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S067
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2016-03-29
- Decision code
- APPR
- Date received
- 2015-08-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the collagen processing equipment cleaning protocol.