STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE
FDA premarket approval P000026/S002 · decided 2009-03-11
Approval details
- PMA number
- P000026
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Trade name
- STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Starr Surgical Co.
- Date received
- 2009-02-09
- Decision date
- 2009-03-11
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- ADDITION OF A NEW REFRIGERATOR AT THE ALISO VIEJO FACILITY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.