PMA P010062S010
- Device
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR AND VISION SHAPING TREATMENT
- Applicant
- Bausch & Lomb
- PMA number
- P010062
- Supplement
- S010
- Product code
- NUU
- Decision date
- 2016-07-25
- Classification
- Lens, Contact, Orthokeratology, Overnight
- Generic name
- Lens, contact, orthokeratology, overnight
- Approval order statement
- Alternate supplier of a critical raw material component.
Current openFDA PMA Record#
- Device
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR AND VISION SHAPING TREATMENT
- Applicant
- Bausch & Lomb
- PMA number
- P010062
- Supplement
- S010
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2016-07-25
- Decision code
- OK30
- Date received
- 2016-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier of a critical raw material component.