PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
FDA premarket approval P900052/S010 · decided 2002-06-11
Approval details
- PMA number
- P900052
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 2001-10-31
- Decision date
- 2002-06-11
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT THE FINISHING/POLISHING FACILITY LOCATED AT ELTRONIC, COON RAPIDS, MINNESOTA.
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