PMA P890039
- Device
- POLY-SAFE(TM) A-TRACK(TM) PACING LEADS
- Applicant
- Cardiac Control Systems, Inc.
- PMA number
- P890039
- Supplement
- S016
- Product code
- DXY
- Decision date
- 1998-11-09
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for the use of BioSpan(R) (MS/0.4 as a raw material for the polyurethane insulation for the above lead models.
Current openFDA PMA Record#
- Device
- POLY-SAFE(TM) A-TRACK(TM) PACING LEADS
- Applicant
- Cardiac Control Systems, Inc.
- PMA number
- P890039
- Supplement
- S016
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 1998-11-09
- Decision code
- APPR
- Date received
- 1996-07-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the use of BioSpan(R) (MS/0.4 as a raw material for the polyurethane insulation for the above lead models.