THINLINE II/FINELINE II STEROX PACING LEADS
FDA premarket approval P960004/S017 · decided 2001-02-15
Approval details
- PMA number
- P960004
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- THINLINE II/FINELINE II STEROX PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2000-12-26
- Decision date
- 2001-02-15
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO. THE MANUFACTURING SITE WILL PERFORM THE STERILIZATION, PACKAGING AND LABELING OF THE DEVICE.
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