BVI 1%OVD
FDA premarket approval P960011/S023 · decided 2013-06-04
Approval details
- PMA number
- P960011
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Trade name
- BVI 1%OVD
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2013-05-08
- Decision date
- 2013-06-04
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- ADD A NEW SYRINGE DENESTER MACHINE AND AN ALTERNATIVE ASSEMBLY AND LABELING MACHINE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.