COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT- MICROFIBRILLAR FORM
FDA premarket approval P810006/S063 · decided 2015-04-16
Approval details
- PMA number
- P810006
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT- MICROFIBRILLAR FORM
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2015-03-20
- Decision date
- 2015-04-16
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- MATERIAL CHANGE FOR THE PIPE THAT LEADS TO CROSSLINKING CHAMBER 2, AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.