COSEAL SURGICAL SEALANT
FDA premarket approval P030039/S007 · decided 2007-11-30
Approval details
- PMA number
- P030039
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COSEAL SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2007-10-31
- Decision date
- 2007-11-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- CHANGE TO A NEW WAREHOUSE FOR STORAGE OF RAW MATERIALS AND FINISHED DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.