This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Paragon Z CRT, Paragon Z CRT Dual Axis |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP050031 Supplement NumberS009 Date Received04/15/2022 Decision Date05/10/2022 Product Codes NUU MWL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-15 |
| Decision Date | 2022-05-10 |
| PMA | P050031 |
| Supplement | S009 |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 san Ramon, CA 94583 PMA NumberP050031 Supplement NumberS009 Date Received04/15/2022 Decision Date05/10/2022 Product Codes NUU MWL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Addition Of A New Power Reader In The Manufacturing Process, The Establishment Of A Fourth Manufacturing Line And A Change In The Blocking Process For Lens Lathing |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050031 | Original Filing | |
| S009 | 2022-04-15 | 30-day Notice |
| S008 | ||
| S007 | 2020-08-05 | 30-day Notice |
| S006 | 2020-08-04 | 30-day Notice |
| S005 | 2019-03-13 | Normal 180 Day Track No User Fee |
| S004 | ||
| S003 | 2019-02-04 | Real-time Process |
| S002 | ||
| S001 | 2010-10-25 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| B22222 | P050031 | 000 |
| B22221 | P050031 | 000 |