SURGICEL ABSORBABLE HEMOSTAT
FDA premarket approval N12159/S028 · decided 2011-09-15
Approval details
- PMA number
- N12159
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Trade name
- SURGICEL ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2011-08-15
- Decision date
- 2011-09-15
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- ADDITION OF NEW PACKAGING EQUIPMENT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.