Helistat® and Helitene® Absorbable Collagen Hemostatic Agents
FDA premarket approval P850010/S102 · decided 2022-05-20
Approval details
- PMA number
- P850010
- Supplement
- S102
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Helistat® and Helitene® Absorbable Collagen Hemostatic Agents
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2022-04-20
- Decision date
- 2022-05-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Replacement of the current two (2) modules of the water purification (RODEI) system with four (4) like-in-kind modules from the same manufacturer to increase purified water capacity at the Integra NeuroSciences manufacturing facility located at Road 402 North, Km 1.2 Añasco, PR 00610.
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