PMA P900052S007
- Device
- PORT-A-CATH EPIDURAL/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
- Applicant
- Smiths Medical Asd, Inc.
- PMA number
- P900052
- Supplement
- S007
- Product code
- LNY
- Decision date
- 1999-04-21
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Approval order statement
- Approval for a change in the postapproval protocol to allow the use of Low Profile system which was approved on 10/28/98.
Current openFDA PMA Record#
- Device
- PORT-A-CATH EPIDURAL/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
- Applicant
- Smiths Medical Asd, Inc.
- PMA number
- P900052
- Supplement
- S007
- Product code
- LNY
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Decision date
- 1999-04-21
- Decision code
- APPR
- Date received
- 1999-02-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for a change in the postapproval protocol to allow the use of Low Profile system which was approved on 10/28/98.