AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICES
FDA premarket approval P000026/S003 · decided 2010-06-17
Approval details
- PMA number
- P000026
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICES
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Starr Surgical Co.
- Date received
- 2010-05-01
- Decision date
- 2010-06-17
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- APPROVAL FOR A MINOR LABELING CHANGE FOR 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.