CARBON TIP CARDIAC PACING LEAD
FDA premarket approval P800041/S015 · decided 1996-01-04
Approval details
- PMA number
- P800041
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBON TIP CARDIAC PACING LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Pacesetter Systems
- Date received
- 1995-10-02
- Decision date
- 1996-01-04
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE ADDITION OF A "NITROGEN BLANKET" TO STERILIZATION PROCESS
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE (K910924) | Pacesetter Systems | 1991-08-28 |
| ENDOCARDIAL SCREW-IN LEAD MODEL 1028T (K902147) | Pacesetter Systems | 1990-07-17 |
| SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS (K900512) | Pacesetter Systems | 1990-06-25 |
| FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T (K900550) | Pacesetter Systems | 1990-04-20 |
| ENDOCARDIAL SCREW-IN LEAD MODEL 1020T (K895447) | Pacesetter Systems | 1989-12-20 |
| CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (K891905) | Pacesetter Systems | 1989-06-05 |
| VS-1 MODEL NUMBER 251K PULSE GENERATOR (K885267) | Pacesetter Systems | 1989-03-28 |
| SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS (K890547) | Pacesetter Systems | 1989-03-22 |