COSEAL SURGICAL SEALANT
FDA premarket approval P030039/S010 · decided 2008-08-18
Approval details
- PMA number
- P030039
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COSEAL SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2008-07-01
- Decision date
- 2008-08-18
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- APPROVAL FOR MODIFICATION TO THE 3 ML SYRINGE FOR THE PEG COMPONENT OF THE 2 ML CONFIGURATION OF THE DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.