STAAR SURGICAL COLLAMER INTRAOCULAR LENSES
FDA premarket approval P990013/S027 · decided 2010-07-29
Approval details
- PMA number
- P990013
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAAR SURGICAL COLLAMER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2010-06-25
- Decision date
- 2010-07-29
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- CHANGE OF THE SOLVENT USED IN THE DEWAXING PROCESS, AND TO IMPLEMENT REDESIGNED SIEVES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.