COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P990013/S034 · decided 2017-04-06
Approval details
- PMA number
- P990013
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2017-03-13
- Decision date
- 2017-04-06
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Modify the hydration step for the Collamer IOL Models CQ2015A and CC4204A and to remove the cometic inspection step for the Collamer IOL Model CC4204A that was performed as part of the hydration process.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.