PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
FDA premarket approval P900052/S006 · decided 1998-09-15
Approval details
- PMA number
- P900052
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 1998-06-04
- Decision date
- 1998-09-15
- Days to decision
- 103 days
- Decision code
- APPR
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for a change in the postapproval protocol to allow the use of anesthetics or analgesics approved for epidural delivery when toxicity symptoms related to the use of preservative-free morphine develop or if there is inadequate pain relief.
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