KARL STORZ D-Light C PDD System
FDA premarket approval P050027/S030 · decided 2022-03-17
Approval details
- PMA number
- P050027
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KARL STORZ D-Light C PDD System
- Generic name
- Light source system, diagnostic endoscopic
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2022-02-16
- Decision date
- 2022-03-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- Manufacturing change to transfer the PDD Cystoscope Monocoil to a vertebrae weld and the PDD Cystoscope Screw Tube sub-assembly weld to be welded by the welder in the Pilot production room.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.