PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
FDA premarket approval P900052/S018 · decided 2013-05-13
Approval details
- PMA number
- P900052
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 2013-04-22
- Decision date
- 2013-05-13
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- CHANGE IN THE SYNTHESIS OF POLYTETRAFLUORO-ETHYLENE (PTFE), A SUBSTANCE USED IN THE MANUFACTURING OF THE COATING SYSTEM FOR THE GUIDEWIRE CONTAINED IN THE PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM. THIS CHANGE IN THE SYNTHESIS OF PTFE IS REQUIRED TO CONFORM TO U.S. ENVIRONMENTAL AGENCY 2010/2015 PFOA STEWARDSHIP PROGRAM RELATED TO THE USE OF PERFLUOROOCTANOIC ACID (PFOA).
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