THINLINE(TM)II/FINELINE(TM) II LEADS
FDA premarket approval P960004/S013 · decided 2000-06-09
Approval details
- PMA number
- P960004
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- THINLINE(TM)II/FINELINE(TM) II LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2000-05-15
- Decision date
- 2000-06-09
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT GUIDANT PUERTO RICO B.V., DORADO, PUERTO RICO, 00646 AND THE STERILIZATION FACILITY LOCATED AT GUIDANT CORPORATION, ST. PAUL, MINNESOTA, 55112.
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