COSEAL SURGICAL SEALANT DEVICE
FDA premarket approval P030039/S013 · decided 2009-09-03
Approval details
- PMA number
- P030039
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COSEAL SURGICAL SEALANT DEVICE
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2009-03-17
- Decision date
- 2009-09-03
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- APPROVAL FOR A NEW SUPPLIER OF PEG COMPONENT MATERIAL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.