PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS
FDA premarket approval P960030/S003 · decided 1998-10-15
Approval details
- PMA number
- P960030
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 1998-09-15
- Decision date
- 1998-10-15
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- The 30-day Notice requested approval for use of parametric release as ana lternate to the current use of biological indicators in the releae of sterilized products.
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