DERMAGRAFT
FDA premarket approval P000036/S009 · decided 2012-04-12
Approval details
- PMA number
- P000036
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Trade name
- DERMAGRAFT
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2012-03-16
- Decision date
- 2012-04-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- ADDITIONAL 50-WATT LASER SYSTEM FOR CUTTING DERMAGRAFT FINAL PRODUCT SAMPLES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.