AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)
FDA premarket approval P800002/S011 · decided 1998-08-10
Approval details
- PMA number
- P800002
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 1998-07-21
- Decision date
- 1998-08-10
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Requested the elimination of the in-vivo hemostasis test, a heavy metals test done at an intermediate bulk stage of Avitene MCH Flour, and the routine performance of finished product sterility testing as part of the sterilization release criteria for each lot of product sterilized.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.