PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST
FDA premarket approval P900052/S002 · decided 1995-10-13
Approval details
- PMA number
- P900052
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 1994-06-28
- Decision date
- 1995-10-13
- Days to decision
- 472 days
- Decision code
- APPR
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR A STERILIZATION PROCESS CHAGE FROM BETA IRRADIATION TO ETHYLENE OXIDE GAS, PACKAGING CHANGES TO A INNER AND OUTER TRAY CONFIGURATION WITH A SHELF CARTON AND REMOVAL (PER OUR GUIDANCE) OF THE SHELF-LIFE STERILITY DATING FOR THE PORT-A-CATH INTRASPINAL IMPLANTABLE ACCESS SYSTEM
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